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

DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE

K Number: K860473 · Decision Aug 14, 1986
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
1
Review Days
189

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Basic Information

Device Name
DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE
K Number
K860473
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
870.1875
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Schering Corp.
Date Received
February 6, 1986
Decision Date
August 14, 1986
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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