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
SUBSCRIBE / SIGN IN
K844467Substantially Equivalent

Oms Cryo

Optical Micro Systems, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844467 is the FDA 510(k) clearance record for OMS CRYO, cleared for Optical Micro Systems, Inc. on . FDA records list 21 510(k) clearances for Optical Micro Systems, Inc., from to . As of , FDA records show no recalls naming K844467.

Clearance record

Decision date
Received
(95 days to decision)
Review panel
Unknown
Applicant
Optical Micro Systems, Inc. 8 Electronics Ave., Danvers MA
Third party review
No