AVITA INFRARED THEROMETER WITH BLUETOOTH


Device Classification Name

thermometer, electronic, clinical

510(k) Number K110559
Device Name AVITA INFRARED THEROMETER WITH BLUETOOTH
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 02/28/2011
Decision Date 01/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No