Cleared Traditional

K895961 - MODEL MC6500 ELECTROCARDIOGRAPH

K895961 is an FDA 510(k) clearance for MODEL MC6500 ELECTROCARDIOGRAPH, manufactured by Cambridge Medical Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K895961 · Cambridge Medical Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
86d
Days
Class 2
Risk

K895961 is an FDA 510(k) clearance for the MODEL MC6500 ELECTROCARDIOGRAPH. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cambridge Medical Instruments, Inc. (Ossining, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cambridge Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K895961

510(k) Number K895961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1989
Decision Date January 04, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
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 117
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K895961.
PR4
K911097 · Mortara Instrument, Inc. · Aug 1991
MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251 · Aequitron Medical, Inc. · May 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793 · Del Mar Avionics · Feb 1990
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227 · Edentec Corp. · Jun 1989
MEDILOG 9000-II AMBULATORY RECORDER
K890647 · Oxford Medilog, Inc. · Mar 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · Del Mar Avionics · Jan 1989