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

VARIOUS TYPES OF STETHOSCOPES

K Number: K905487 · Decision Apr 9, 1991
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
6
Review Days
124

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Basic Information

Device Name
VARIOUS TYPES OF STETHOSCOPES
K Number
K905487
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
870.1875
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Liaoning-Usa Corp.
Date Received
December 6, 1990
Decision Date
April 9, 1991
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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K Number Device Name
K911921 DISPOSABLE ISOLATION GOWN
K910623 GAUZE SPONGES ABSORBENT GAUZE ROLLS
K902625 CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT
K892781 ANTELOPE BRAND PATIENT EXAMINATION GLOVES
K892774 PATIENT EXAMINATION GLOVES