510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K802112Substantially Equivalent

Pa-1 Low Pressure Alarm

Medtronic, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802112 is the FDA 510(k) clearance record for PA-1 LOW PRESSURE ALARM, 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 K802112.

Clearance record

Decision date
Received
(3 days to decision)
Review panel
Unknown
Applicant
Puritan Bennett Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No