510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820941Substantially Equivalent

Therma-Scan

T. G. & E. Medical, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820941 is the FDA 510(k) clearance record for THERMA-SCAN, cleared for T. G. & E. Medical on . FDA records list 5 510(k) clearances for T. G. & E. Medical, from to . As of , FDA records show no recalls naming K820941.

Clearance record

Decision date
Received
(71 days to decision)
Review panel
Unknown
Applicant
T. G. & E. Medical 803 N. Front St. Suite 3, Mchenry IL
Third party review
No