TEMPORALSCANNER THERMOMETER, SENSORTOUCH


Device Classification Name

thermometer, electronic, clinical

510(k) Number K011291
Device Name TEMPORALSCANNER THERMOMETER, SENSORTOUCH
Original Applicant
EXERGEN CORP.
601 13th street, nw
washington, 
DC 
20005

Original Contact william hare
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 04/27/2001
Decision Date 07/12/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No