510(k) K820941
K820941 is an FDA 510(k) premarket notification submitted by T. G. & E. Medical for the device "THERMA-SCAN". The FDA issued a decision of Substantially Equivalent on June 16, 1982. T. G. & E. Medical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1982
- Date Received
- April 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No