510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K837322Substantially Equivalent

Novo Cerebrograph

Novo Diagnostic Systems, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837322 is the FDA 510(k) clearance record for NOVO CEREBROGRAPH, cleared for Novo Diagnostic Systems on . FDA records list 2 510(k) clearances for Novo Diagnostic Systems, from to . As of , FDA records show no recalls naming K837322.

Clearance record

Decision date
Received
(28 days to decision)
Review panel
Unknown
Applicant
Novo Diagnostic Systems 4221 Richmond Rd., NW, Walker MI
Third party review
No