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

STETH-SHIELD ACCESSORY TO A STETHOSCOPE

K Number: K882324 · Decision Jul 18, 1988
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
1
Review Days
42

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Basic Information

Device Name
STETH-SHIELD ACCESSORY TO A STETHOSCOPE
K Number
K882324
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
870.1875
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Steth-Shield, Inc.
Date Received
June 6, 1988
Decision Date
July 18, 1988
Product Code
LDE
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
LDE Stethoscope, Manual

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