510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K812015Substantially Equivalent

Glaukon

Sonometrics Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812015 is the FDA 510(k) clearance record for GLAUKON, cleared for Sonometrics Systems, Inc. on . FDA records list 4 510(k) clearances for Sonometrics Systems, Inc., from to . As of , FDA records show no recalls naming K812015.

Clearance record

Decision date
Received
(206 days to decision)
Review panel
Unknown
Applicant
Sonometrics Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No