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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K841875Substantially Equivalent

Heart-Check ECG Transmitter

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

K841875 is the FDA 510(k) clearance record for HEART-CHECK ECG TRANSMITTER, cleared for Physio Ventures, Inc. on . FDA records list one 510(k) clearance for Physio Ventures, Inc. As of , FDA records show no recalls naming K841875.

Clearance record

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