510(k) K240158

Modular Medical MODD1 Insulin Delivery System by Modular Medical, Inc. — Product Code LZG

K240158 is an FDA 510(k) premarket notification submitted by Modular Medical, Inc. for the device "Modular Medical MODD1 Insulin Delivery System". The FDA issued a decision of Substantially Equivalent on September 4, 2024. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Modular Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2024
Date Received
January 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type