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
K827450Substantially Equivalent

Simplamatic III

Spectrum X-Ray Corp., Westville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827450 is the FDA 510(k) clearance record for SIMPLAMATIC III, cleared for Spectrum X-Ray Corp. on . FDA records list 9 510(k) clearances for Spectrum X-Ray Corp., from to . As of , FDA records show no recalls naming K827450.

Clearance record

Decision date
Received
(22 days to decision)
Review panel
Unknown
Applicant
Spectrum X-Ray Corp. P.O. Box 155 Ryan Ave., Westville NJ
Third party review
No