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

MICROMED QRS CARD

K Number: K903722 · Decision Dec 5, 1990
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
112

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Basic Information

Device Name
MICROMED QRS CARD
K Number
K903722
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2340
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Nasiff Assoc., Inc.
Date Received
August 15, 1990
Decision Date
December 5, 1990
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

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K972795 CARDIO-CARD MANAGEMENT SYSTEM II
K960544 CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
K920020 CARDIO-CARD ECG MANAGEMENT SYSTEM