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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K914488
Device Name MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
Applicant
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Applicant Contact EDWARD A KROLL
Correspondent
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Correspondent Contact EDWARD A KROLL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/08/1991
Decision Date 09/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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