510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K851366Substantially Equivalent

Companion 2800 Volume Ventilator

Medtronic, Inc., Overland Park KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851366 is the FDA 510(k) clearance record for COMPANION 2800 VOLUME VENTILATOR, cleared for Puritan Bennett Corp. on . FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K851366.

Clearance record

Decision date
Received
(201 days to decision)
Review panel
Unknown
Applicant
Puritan Bennett Corp. 9401 Indian Creek Pkwy., Overland Park KS
Third party review
No