Cleared Traditional

K062282 - MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0

K062282 is an FDA 510(k) clearance for MONEBO AUTOMATED ECG ANALYSIS AND INTER..., manufactured by Monebo Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K062282 · Monebo Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
227d
Days
Class 2
Risk

K062282 is an FDA 510(k) clearance for the MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Monebo Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on March 22, 2007 after a review of 227 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K062282

510(k) Number K062282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2006
Decision Date March 22, 2007
Days to Decision 227 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 125d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 535
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K062282.
PALM ECG RECORDER, MODEL EP-201/202
K061123 · Parama-Tech Company., Ltd. · Jun 2007
CORSCREEN
K070614 · Viasys Healthcare GmbH · May 2007
AUDICOR 200 SYSTEM, MODELS 200D AND 200S
K070136 · Inovise Medical, Inc. · Apr 2007
MORTARA ELI 10 ELECTROCARDIOGRAPH
K070539 · Mortara Instrument, Inc. · Mar 2007
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
K062894 · Dailycare Biomedical, Inc. · Feb 2007
ELI 350 ELECTROCARDIOGRAPH
K062677 · Mortara Instrument, Inc. · Nov 2006
K062282 · MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
Download PDF FDA Summary Monebo Technologies, …