510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864394Substantially Equivalent

Emerson 3Mv Volume Ventilator

J. H. Emerson Co., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864394 is the FDA 510(k) clearance record for EMERSON 3MV VOLUME VENTILATOR, cleared for J. H. Emerson Co. on . FDA records list 25 510(k) clearances for J. H. Emerson Co., from to . As of , FDA records show no recalls naming K864394.

Clearance record

Decision date
Received
(29 days to decision)
Review panel
Unknown
Applicant
J. H. Emerson Co. 22 Cottage Park Ave., Cambridge MA
Third party review
No