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
SUBSCRIBE / SIGN IN
K812695Substantially Equivalent

Disk

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

K812695 is the FDA 510(k) clearance record for DISK, cleared for American Heartline, Inc. on . FDA records list 2 510(k) clearances for American Heartline, Inc., from to . As of , FDA records show no recalls naming K812695.

Clearance record

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