510(k) K180842

MAC Medical D-Series Blanket and Solution Warming Cabinets by Mac Medical, Inc. — Product Code LGZ

K180842 is an FDA 510(k) premarket notification submitted by Mac Medical, Inc. for the device "MAC Medical D-Series Blanket and Solution Warming Cabinets". The FDA issued a decision of Substantially Equivalent on March 5, 2019. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Mac Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2019
Date Received
March 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type