Cleared Traditional

K061993 - EQUIVITAL, MODEL EQ-01

K061993 is an FDA 510(k) clearance for EQUIVITAL, manufactured by Hidalgo Limited. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K061993 · Hidalgo Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
112d
Days
Class 2
Risk

K061993 is an FDA 510(k) clearance for the EQUIVITAL, MODEL EQ-01. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Hidalgo Limited (Swavesey Cambridge, GB). The FDA issued a Cleared decision on November 3, 2006 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hidalgo Limited devices

FDA 510(k) Submission Details - K061993

510(k) Number K061993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2006
Decision Date November 03, 2006
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 349
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K061993.
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
K062324 · Ge Healthcare · Dec 2006
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
K062271 · Philips Medical Systems · Nov 2006
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
K063315 · Philips Medizin Systeme Boeblingen GmbH · Nov 2006
ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
K062144 · Invivo Corporation · Oct 2006
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K062095 · Spacelabs Medical, Inc. · Sep 2006
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES
K062576 · Ge Healthcare · Sep 2006