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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 K961126
Device Name PULSE DOSE SERIES
Applicant
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Applicant Contact GREGORY W GOOD
Correspondent
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Correspondent Contact GREGORY W GOOD
Regulation Number868.5905
Classification Product Code
NFB  
Date Received03/21/1996
Decision Date 10/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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