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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 K851438
Device Name MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
Applicant
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact OTMAR H SACKERLOTSK
Correspondent
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact OTMAR H SACKERLOTSK
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/10/1985
Decision Date 07/29/1985
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
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