510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837331Substantially Equivalent

Corneomap 4500 Ultrasound Measurement

Radionics Medical, Inc., Scarborough, Ontario, Can, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837331 is the FDA 510(k) clearance record for CORNEOMAP 4500 ULTRASOUND MEASUREMENT, cleared for Radionics Medical, Inc. on . FDA records list 5 510(k) clearances for Radionics Medical, Inc., from to . As of , FDA records show no recalls naming K837331.

Clearance record

Decision date
Received
(60 days to decision)
Review panel
Unknown
Applicant
Radionics Medical, Inc. 1240 Ellesmere Rd., Scarborough, Ontario, Can, CA
Third party review
No