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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863987
Device Name BI-TEMP TEMPERATURE MONITOR
Applicant
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Applicant Contact ANTHONY BERAN
Correspondent
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Correspondent Contact ANTHONY BERAN
Date Received10/14/1986
Decision Date 11/18/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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