510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K827087Substantially Equivalent

P1808 Mobile C-Arm Image Intensifier

Precise Optics, Bay Shore NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827087 is the FDA 510(k) clearance record for P1808 MOBILE C-ARM IMAGE INTENSIFIER, cleared for Precise Optics on . FDA records list 13 510(k) clearances for Precise Optics, from to . As of , FDA records show no recalls naming K827087.

Clearance record

Decision date
Received
(41 days to decision)
Review panel
Unknown
Applicant
Precise Optics 239 S. Fehr Way, Bay Shore NY
Third party review
No