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

PENLON PPV VAPORIZER

K Number: K844007 · Decision Mar 12, 1985
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
10
Review Days
151

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Basic Information

Device Name
PENLON PPV VAPORIZER
K Number
K844007
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5880
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Penlon, Inc.
Date Received
October 12, 1984
Decision Date
March 12, 1985
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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Other Clearances by Penlon, Inc.

K Number Device Name
K936046 SIGMA ELITE
K902381 PENLON BREATHING SYSTEM PRESSURE MONITOR
K894689 PENLON IDP PRESSURE FAILURE ALARM
K844008 PENLON AM1000 ANAESTHESIA MACHINE
K823555 MAGTARAK RESPIRATORY MONITOR & FLOW SENS
K803052 NUFFIELD ANESTHESIA VENTILATOR SER. 400
K801253 CREST ELECTRONIC WARMING BLANKET
K801254 PENLON I.D.P. PRESSSURE FAILURE ALARM
K801255 PENLON JUMBO CARBON DIOXIDE ABSORBER