TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX


Device Classification Name

thermometer, electronic, clinical

510(k) Number K030299
Device Name TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
Original Applicant
ORIENTAL SYSTEM TECHNOLOGY, INC.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact susan d goldstein-falk
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 01/29/2003
Decision Date 02/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No