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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 K913083
FOIA Releasable 510(k) K913083
Device Name BI-TEMP TEMPERATURE MONITOR TM-201D
Applicant
Respiratory Support Products, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92614
Applicant Contact GORDON SHIGEZAWA
Correspondent
Respiratory Support Products, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92614
Correspondent Contact GORDON SHIGEZAWA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/23/1991
Decision Date 10/17/1991
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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