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

DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2

K Number: K002047 · Decision Nov 22, 2000
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
13
Review Days
139

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Basic Information

Device Name
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
K Number
K002047
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1875
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Doctor'S Research Group, Inc.
Date Received
July 6, 2000
Decision Date
November 22, 2000
Product Code
DQD
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
DQD Stethoscope, Electronic

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