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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K837443Substantially Equivalent

Om-1 Diaphanography Light Transillumination System Sor Mammography

Medical Diagnostic Instruments, Inc., Hamden CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837443 is the FDA 510(k) clearance record for OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY, cleared for Medical Diagnostic Instruments, Inc. on . FDA records list one 510(k) clearance for Medical Diagnostic Instruments, Inc. As of , FDA records show no recalls naming K837443.

Clearance record

Decision date
Received
(42 days to decision)
Review panel
Unknown
Applicant
Medical Diagnostic Instruments, Inc. 925 Sherman Ave., Hamden CT
Third party review
No