FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

DYNAMIC SPECTRAL PHONOCARDIOGRAPH

K Number: K902185 · Decision Mar 25, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
17
Applicant Total
1
Review Days
315

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Basic Information

Device Name
DYNAMIC SPECTRAL PHONOCARDIOGRAPH
K Number
K902185
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
870.2390
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Reeves Scientific, Inc.
Date Received
May 14, 1990
Decision Date
March 25, 1991
Product Code
DQC
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
DQC Phonocardiograph

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