510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K828619Substantially Equivalent

Ohmicron Mammography X-Ray System Model Omc 4520M

Ohmic, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828619 is the FDA 510(k) clearance record for OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M, cleared for Ohmic , Ltd. on . FDA records list one 510(k) clearance for Ohmic , Ltd. As of , FDA records show no recalls naming K828619.

Clearance record

Decision date
Received
(41 days to decision)
Review panel
Unknown
Applicant
Ohmic , Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No