510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K862593Substantially Equivalent

Das 211

Philips North America LLC, Highland Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862593 is the FDA 510(k) clearance record for DAS 211, cleared for Philips Medical Systems (Cleveland), Inc. on . FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K862593.

Clearance record

Decision date
Received
(62 days to decision)
Review panel
Unknown
Applicant
Philips Medical Systems (Cleveland), Inc. 5500 Avion Park Dr., Highland Heights OH
Third party review
No