510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K827818Substantially Equivalent

Doppler Flow Meter, Laser

Atl Interspec Cardiology, Ambler PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827818 is the FDA 510(k) clearance record for DOPPLER FLOW METER, LASER, cleared for Atl Interspec Cardiology on . FDA records list one 510(k) clearance for Atl Interspec Cardiology. As of , FDA records show no recalls naming K827818.

Clearance record

Decision date
Received
(29 days to decision)
Review panel
Unknown
Applicant
Atl Interspec Cardiology 110 W. Butler Ave., Ambler PA
Third party review
No