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
SUBSCRIBE / SIGN IN
K827284Substantially Equivalent

Model Ssd-119

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

K827284 is the FDA 510(k) clearance record for MODEL SSD-119, cleared for Aloka Co., Ltd. on . FDA records list one 510(k) clearance for Aloka Co., Ltd. As of , FDA records show no recalls naming K827284.

Clearance record

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