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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 K983627
Device Name VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
Applicant
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036 -2125
Applicant Contact EDWARD A KROLL
Correspondent
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036 -2125
Correspondent Contact EDWARD A KROLL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/15/1998
Decision Date 10/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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