Cleared Traditional

K070014 - AUTO DETECT FOR TELAHEART DR200/E-A

K070014 is an FDA 510(k) clearance for AUTO DETECT FOR TELAHEART DR200/E-A, manufactured by North East Monitoring, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K070014 · North East Monitoring, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
142d
Days
Class 2
Risk

K070014 is an FDA 510(k) clearance for the AUTO DETECT FOR TELAHEART DR200/E-A. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by North East Monitoring, Inc. (Shelton, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 - K070014

510(k) Number K070014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date May 25, 2007
Days to Decision 142 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
17d slower than avg
Panel avg: 125d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070014.
E3-80 PORTABLE ECG RECORDER & ANALYZER
K071085 · Micro-Star International Co., Ltd. · Oct 2007
DL900 SERIES HOLTER RECORDER
K071733 · Braemar, Inc. · Jul 2007
CARDIOMEM CM 3000-12BT
K063042 · Getemed Medizin- Und Informationstechnik AG · May 2007
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
K071011 · Braemar, Inc. · Apr 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