Cleared Traditional

ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW (K984089) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984089 · Zymed Medical Instrumentation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
92d
Days
Class 2
Risk

K984089 is an FDA 510(k) clearance for the ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Zymed Medical Instrumentation (Camarillo, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 92 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 Zymed Medical Instrumentation devices

Submission Details

510(k) Number K984089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date February 16, 1999
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K984089.
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
K992908 · Quinton, Inc. · Mar 2000
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516 · Hewlett-Packard Co. · Nov 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171 · Hewlett-Packard Co. · Oct 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376 · Hewlett-Packard Co. · Jan 1999
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
K983980 · Siemens Medical Solutions USA, Inc. · Nov 1998
SIEMENS SC 8000 BEDSIDE MONITOR
K983632 · Siemens Medical Solutions USA, Inc. · Nov 1998