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

VAPLOK

K Number: K864605 · Decision Feb 3, 1987
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
28
Review Days
71

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Basic Information

Device Name
VAPLOK
K Number
K864605
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5880
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Bear Medical Systems, Inc.
Date Received
November 24, 1986
Decision Date
February 3, 1987
Product Code
CAD
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
CAD Vaporizer, Anesthesia, Non-Heated

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K912619 BEAR 7 VENTILATOR
K900637 BEAR CEM CONTROLLER
K896315 BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
K893034 VHS 820 HUMIDIFIER, MODIFICATION
K890724 MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K882764 BEAR EVC-100 CONTROLLER
K881335 BEAR 3 VENTILATOR
K872660 BEAR NVM-1
Search all 28 clearances from Bear Medical Systems, Inc. →