Cleared Traditional

K960925 - NORTHEAST MONITORING DR180

K960925 is an FDA 510(k) clearance for NORTHEAST MONITORING DR180, manufactured by North East Monitoring, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K960925 · North East Monitoring, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
147d
Days
Class 2
Risk

K960925 is an FDA 510(k) clearance for the NORTHEAST MONITORING DR180. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by North East Monitoring, Inc. (Sudbury, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 147 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.

View all North East Monitoring, Inc. devices

FDA 510(k) Submission Details - K960925

510(k) Number K960925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1996
Decision Date July 31, 1996
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
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 - DSH Recorder, Magnetic Tape, Medical

All 83
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K960925.
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
K974420 · Hewlett-Packard Co. · Feb 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604 · Alexander Mfg. Co. · Jul 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174 · Del Mar Avionics · Mar 1997
HOLTER PACERCORDER(R)
K950020 · Del Mar Avionics · Aug 1995
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
K951605 · Spacelabs, Inc. · Jul 1995
HOLTER SSR DIGICORDER(TM)
K942653 · Del Mar Avionics · May 1995