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

LARYNGESCOPE

K Number: K831981 · Decision Sep 29, 1983
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
6
Review Days
101

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Basic Information

Device Name
LARYNGESCOPE
K Number
K831981
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5540
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
W.E. Leder Enterprises, Inc.
Date Received
June 20, 1983
Decision Date
September 29, 1983
Product Code
CCW
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CCW Laryngoscope, Rigid

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Other Clearances by W.E. Leder Enterprises, Inc.

K Number Device Name
K831877 ARF 850 E
K831878 CARDIO-SCOPE MINI MONITOR
K830161 ANESTHESIA APATATUS #D-25
K830159 ANESTHESIA APPARATUS PH-35
K830160 ANESTHESIA APPARATUS #FO 20S