FDA 510(k) Application Details - K241506

Device Classification Name Pump, Breast, Powered

  More FDA Info for this Device
510(K) Number K241506
Device Name Pump, Breast, Powered
Applicant Annabella Tech
23/5 Hataas
Kfar Saba 4442525 IL
Other 510(k) Applications for this Company
Contact Dalia Dickman
Other 510(k) Applications for this Contact
Regulation Number 884.5160

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

  More FDA Info for this Product Code
Date Received 05/28/2024
Decision Date 06/27/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241506


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