AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES


Device Classification Name

thermometer, electronic, clinical

510(k) Number K081160
Device Name AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
Applicant
AVITA CORPORATION
2904 n. boldt dr.
flagstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
AVITA CORPORATION
2904 n. boldt dr.
flagstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 04/23/2008
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No