510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K800073Substantially Equivalent

Transcutaneous Oxygen Monitor

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

K800073 is the FDA 510(k) clearance record for TRANSCUTANEOUS OXYGEN MONITOR, cleared for Biochem International, Inc. on . FDA records list 28 510(k) clearances for Biochem International, Inc., from to . As of , FDA records show no recalls naming K800073.

Clearance record

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