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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 K003939
Device Name VENTURE HOME FILL II, MODEL IOH 200
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 Number868.5440
Classification Product Code
CAW  
Date Received12/21/2000
Decision Date 03/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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