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
K827796Substantially Equivalent

Innoscan Examination Light

Innomed, Inc., Rye Brook NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827796 is the FDA 510(k) clearance record for INNOSCAN EXAMINATION LIGHT, cleared for Innomed Corp. on . FDA records list 3 510(k) clearances for Innomed Corp., from to . As of , FDA records show no recalls naming K827796.

Clearance record

Decision date
Received
(26 days to decision)
Review panel
Unknown
Applicant
Innomed Corp. 10 Rye Ridge Plz., Rye Brook NY
Third party review
No