510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K837314Substantially Equivalent

Sdl-10 Diagnostic Ultrasound

Shimadzu Corp., Kyoto City 604 Japan, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837314 is the FDA 510(k) clearance record for SDL-10 DIAGNOSTIC ULTRASOUND, cleared for Shimadzu Corp. on . FDA records list 58 510(k) clearances for Shimadzu Corp., from to . As of , FDA records show no recalls naming K837314.

Clearance record

Decision date
Received
(38 days to decision)
Review panel
Unknown
Applicant
Shimadzu Corp. 1 Nishinokyo-Kuwabaracho, Kyoto City 604 Japan, JP
Third party review
No