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
K820958Substantially Equivalent

Digilog System

Medical Design Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820958 is the FDA 510(k) clearance record for DIGILOG SYSTEM, cleared for Medical Design Laboratories, Inc. on . FDA records list one 510(k) clearance for Medical Design Laboratories, Inc. As of , FDA records show no recalls naming K820958.

Clearance record

Decision date
Received
(37 days to decision)
Review panel
Unknown
Applicant
Medical Design Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No