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
K837430Substantially Equivalent

Auto D Option

Technicare Corp., Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837430 is the FDA 510(k) clearance record for AUTO D OPTION, cleared for Technicare Corp. on . FDA records list 32 510(k) clearances for Technicare Corp., from to . As of , FDA records show no recalls naming K837430.

Clearance record

Decision date
Received
(19 days to decision)
Review panel
Unknown
Applicant
Technicare Corp. 29100 Aurora Rd., Solon OH
Third party review
No