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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K962869
Device Name GSP1 - GAS SELECTION PANEL
Applicant
Reimers Systems, Inc.
7668 Fullerton Rd., Suite I-4
Springfield,  VA  22153
Applicant Contact STEPHEN D REIMERS
Correspondent
Reimers Systems, Inc.
7668 Fullerton Rd., Suite I-4
Springfield,  VA  22153
Correspondent Contact STEPHEN D REIMERS
Regulation Number868.5470
Classification Product Code
CBF  
Date Received07/23/1996
Decision Date 10/23/1996
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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