510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852108Substantially Equivalent

Newport Ventilator Model E-100

Newport Medical Instruments, Inc., Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852108 is the FDA 510(k) clearance record for NEWPORT VENTILATOR MODEL E-100, cleared for Newport Medical Instruments, Inc. on . FDA records list 23 510(k) clearances for Newport Medical Instruments, Inc., from to . As of , FDA records show no recalls naming K852108.

Clearance record

Decision date
Received
(126 days to decision)
Review panel
Unknown
Applicant
Newport Medical Instruments, Inc. P.O. Box 2600, Newport Beach CA
Third party review
No