510(k) K812799

DCATS by Dorex, Inc. — Product Code IYM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1981
Date Received
October 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic, Infrared
Device Class
Class III
Regulation Number
884.2980
Review Panel
RA
Submission Type