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
K861163Substantially Equivalent

Xtal X-800 Shadowgraph

Xtal Corp., Solana Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861163 is the FDA 510(k) clearance record for XTAL X-800 SHADOWGRAPH, cleared for Xtal Corp. on . FDA records list 2 510(k) clearances for Xtal Corp., from to . As of , FDA records show no recalls naming K861163.

Clearance record

Decision date
Received
(39 days to decision)
Review panel
Unknown
Applicant
Xtal Corp. 215 S. Hwy. 101, Solana Beach CA
Third party review
No