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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K871337
Device Name M-2 OXYGEN/TEMPERATURE MONITOR
Applicant
Bio-Med Devices, Inc.
8 Bishop Ln.
Madison,  CT  06443
Applicant Contact DEAN J BENNETT
Correspondent
Bio-Med Devices, Inc.
8 Bishop Ln.
Madison,  CT  06443
Correspondent Contact DEAN J BENNETT
Regulation Number868.1720
Classification Product Code
CCL  
Date Received04/03/1987
Decision Date 06/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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