510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837304Substantially Equivalent

Models 246 and 210F Linear Array Ultrasound Scanner

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

K837304 is the FDA 510(k) clearance record for MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER, cleared for Aloka Co., Ltd. on . FDA records list 3 510(k) clearances for Aloka Co., Ltd., from to . As of , FDA records show no recalls naming K837304.

Clearance record

Decision date
Received
(52 days to decision)
Review panel
Unknown
Applicant
Aloka Co., Ltd. 6-22-1, Mure, Mitaka-Shi, Tokyo, JP
Third party review
No