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

MODEL 350G GAS CONSERVER

K Number: K090421 · Decision May 29, 2009
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
2
Review Days
100

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Basic Information

Device Name
MODEL 350G GAS CONSERVER
K Number
K090421
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5905
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Inspired Technologies, Inc.
Date Received
February 18, 2009
Decision Date
May 29, 2009
Product Code
NFB
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
NFB Conserver, Oxygen

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Other Clearances by Inspired Technologies, Inc.

K Number Device Name
K082853 CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR