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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, oxygen, gaseous-phase
510(k) Number K984295
Device Name INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
Applicant
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036
Applicant Contact EDWARD A KROLL
Correspondent
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036
Correspondent Contact EDWARD A KROLL
Regulation Number868.1720
Classification Product Code
CCL  
Date Received12/01/1998
Decision Date 07/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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