510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837171Substantially Equivalent

Ultrasonic Echoscope

Ausonics Pty, Ltd., Austrailia / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837171 is the FDA 510(k) clearance record for ULTRASONIC ECHOSCOPE, cleared for Ausonics Pty , Ltd. on . FDA records list 27 510(k) clearances for Ausonics Pty , Ltd., from to . As of , FDA records show no recalls naming K837171.

Clearance record

Decision date
Received
(29 days to decision)
Review panel
Unknown
Applicant
Ausonics Pty , Ltd. 16 Mars Rd., Austrailia
Third party review
No