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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K134014
Device Name TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
Applicant
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
THE OLD COACH HOUSE, THE AV.
FARLEIGH WALLOP, BASINGSTOKE
HAMPSHIRE,  GB RG25 2HT
Applicant Contact LEIGH CORNOCK
Correspondent
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
THE OLD COACH HOUSE, THE AV.
FARLEIGH WALLOP, BASINGSTOKE
HAMPSHIRE,  GB RG25 2HT
Correspondent Contact LEIGH CORNOCK
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
ITX   IYO  
Date Received12/30/2013
Decision Date 08/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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