AVITA TSO/TS1 INFRARED EAR THERMOMETER


information about

Device Classification Name

thermometer, electronic, clinical

510(k) Number K002182
Device Name AVITA TSO/TS1 INFRARED EAR THERMOMETER
Original Applicant
AVITA CORPORATION
900 n. switzer canyon dr. #142
flaggstaff, 
AZ 
86001

Original Contact allen reich
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 07/19/2000
Decision Date 12/29/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No