510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837378Substantially Equivalent

Omnimedical Quad II Digital Angiograph System

Omnimedical, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837378 is the FDA 510(k) clearance record for OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM, cleared for Omnimedical on . FDA records list 6 510(k) clearances for Omnimedical, from to . As of , FDA records show no recalls naming K837378.

Clearance record

Decision date
Received
(62 days to decision)
Review panel
Unknown
Applicant
Omnimedical 803 N. Front St. Suite 3, Mchenry IL
Third party review
No