FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH

K Number: K883454 · Decision Jan 25, 1989
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
8
Review Days
163

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH
K Number
K883454
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2340
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Cambridge Medical Instruments, Inc.
Date Received
August 15, 1988
Decision Date
January 25, 1989
Product Code
DPS
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DPS Electrocardiograph

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (DPS), ordered by most recent decision date.

View all

Other Clearances by Cambridge Medical Instruments, Inc.

K Number Device Name
K896772 EKG, ECG KENZ, ECG 303
K896771 EKG, ECG KENZ, ECG 302
K895961 MODEL MC6500 ELECTROCARDIOGRAPH
K871993 MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH
K862748 MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION
K854282 PREVIEW XT
K854283 CAMBRIDGE MODEL XT1000