FDA 510(k) Application Details - K240158

Device Classification Name Pump, Infusion, Insulin

  More FDA Info for this Device
510(K) Number K240158
Device Name Pump, Infusion, Insulin
Applicant Modular Medical, Inc.
10740 Thornmint Road
San Diego, CA 92127 US
Other 510(k) Applications for this Company
Contact Kelsie DiPerna
Other 510(k) Applications for this Contact
Regulation Number 880.5725

  More FDA Info for this Regulation Number
Classification Product Code LZG
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/19/2024
Decision Date 09/04/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240158


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact