510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K827209Substantially Equivalent

System 287 Scanner

Diagnostic Sonar USA, Cambridge OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827209 is the FDA 510(k) clearance record for SYSTEM 287 SCANNER, cleared for Diagnostic Sonar USA on . FDA records list 2 510(k) clearances for Diagnostic Sonar USA, from to . As of , FDA records show no recalls naming K827209.

Clearance record

Decision date
Received
(45 days to decision)
Review panel
Unknown
Applicant
Diagnostic Sonar USA 67079 Read Rd., Cambridge OH
Third party review
No