510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K781219Substantially Equivalent

Econ-O2

Mountain Medical Equipment, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781219 is the FDA 510(k) clearance record for ECON-O2, cleared for Mountain Medical Equipment, Inc. on . FDA records list 20 510(k) clearances for Mountain Medical Equipment, Inc., from to . As of , FDA records show no recalls naming K781219.

Clearance record

Decision date
Received
(45 days to decision)
Review panel
Unknown
Applicant
Mountain Medical Equipment, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No