TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921


codes

Device Classification Name

thermometer, electronic, clinical

510(k) Number K001008
Device Name TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
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 03/29/2000
Decision Date 04/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Special
Reviewed by Third Party No

Combination Product

No