The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Tso/ts1 Infrared Ear Thermometer.
Device ID | K002182 |
510k Number | K002182 |
Device Name: | AVITA TSO/TS1 INFRARED EAR THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | AVITA CORPORATION 900 N. SWITZER CANYON DR. #142 Flaggstaff, AZ 86001 |
Contact | Allen Reich |
Correspondent | Allen Reich AVITA CORPORATION 900 N. SWITZER CANYON DR. #142 Flaggstaff, AZ 86001 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-19 |
Decision Date | 2000-12-29 |