510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K841048Substantially Equivalent

Transducer 4.Omhz La4011

Philips North America LLC, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841048 is the FDA 510(k) clearance record for TRANSDUCER 4.OMHZ LA4011, cleared for Philips Ultrasound, Inc. on . FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K841048.

Clearance record

Decision date
Received
(319 days to decision)
Review panel
Unknown
Applicant
Philips Ultrasound, Inc. 2722 S. Fairview, Santa Ana CA
Third party review
No