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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 K970371
Device Name FLOTEC OXYSAVRR (S)
Applicant
Flotec, Inc.
8132 Woodland Dr.
Indianapolis,  IN  46278
Applicant Contact GILBERT DAVIDSON
Correspondent
Flotec, Inc.
8132 Woodland Dr.
Indianapolis,  IN  46278
Correspondent Contact GILBERT DAVIDSON
Regulation Number868.5905
Classification Product Code
NFB  
Date Received01/31/1997
Decision Date 07/10/1997
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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