510(k) K240158
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