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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K002284
Device Name VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
Applicant
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036 -2125
Applicant Contact EDWARD A KROLL
Correspondent
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036 -2125
Correspondent Contact EDWARD A KROLL
Regulation Number868.5905
Classification Product Code
NFB  
Date Received07/26/2000
Decision Date 10/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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