510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K827663Substantially Equivalent

Sinuson 810 Ultrasound Scanner

Am Labs, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827663 is the FDA 510(k) clearance record for SINUSON 810 ULTRASOUND SCANNER, cleared for Am Labs, Inc. on . FDA records list 2 510(k) clearances for Am Labs, Inc., from to . As of , FDA records show no recalls naming K827663.

Clearance record

Decision date
Received
(47 days to decision)
Review panel
Unknown
Applicant
Am Labs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No