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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K863646
Device Name ESOPHAGEAL RECTAL TEMPERATURE PROBE
Applicant
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Applicant Contact ANTHONY V BERAN
Correspondent
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Correspondent Contact ANTHONY V BERAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/18/1986
Decision Date 11/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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