510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820652Substantially Equivalent

Exhaled Hydrogen Monitor

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

K820652 is the FDA 510(k) clearance record for EXHALED HYDROGEN MONITOR, cleared for Keymed, Inc. on . FDA records list 29 510(k) clearances for Keymed, Inc., from to . As of , FDA records show no recalls naming K820652.

Clearance record

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