Cleared Special

K071011 - MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER

K071011 is an FDA 510(k) clearance for MODIFICATION TO: BRAEMAR ER900 SERIES E..., manufactured by Braemar, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Special 510(k) pathway after a 17-day FDA review.

K071011 · Braemar, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
17d
Days
Class 2
Risk

K071011 is an FDA 510(k) clearance for the MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Braemar, Inc. (Eagan, US). The FDA issued a Cleared decision on April 27, 2007 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071011

510(k) Number K071011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2007
Decision Date April 27, 2007
Days to Decision 17 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 63
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K071011.
DL900 SERIES HOLTER RECORDER
K071733 · Braemar, Inc. · Jul 2007
CARDIOMEM CM 3000-12BT
K063042 · Getemed Medizin- Und Informationstechnik AG · May 2007
AUTO DETECT FOR TELAHEART DR200/E-A
K070014 · North East Monitoring, Inc. · May 2007
DMS 300-2, 300-3 AND 300-4
K062959 · Diagnostic Monitoring Software · Oct 2006
TELAHEART DIGITAL RECORDER
K061293 · North East Monitoring, Inc. · Aug 2006
CARDIOMEM CM 3000-12
K051686 · Getemed Medizin- Und Informationstechnik AG · Jul 2005
K071011 · MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
Download PDF Braemar, Inc.