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
SUBSCRIBE / SIGN IN
K770829Substantially Equivalent

Recording Unit, Model 1445

Scole Engineering Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770829 is the FDA 510(k) clearance record for RECORDING UNIT, MODEL 1445, cleared for Scole Engineering Co. on . FDA records list 4 510(k) clearances for Scole Engineering Co., from to . As of , FDA records show no recalls naming K770829.

Clearance record

Decision date
Received
(13 days to decision)
Review panel
Unknown
Applicant
Scole Engineering Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No