FDA 510(k) Application Details - K210936

Device Classification Name Pump, Breast, Powered

  More FDA Info for this Device
510(K) Number K210936
Device Name Pump, Breast, Powered
Applicant Chiaro Technology Limited
2nd Floor 63-66 Hatton Garden
London EC1N 8LE GB
Other 510(k) Applications for this Company
Contact Carre King
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 03/29/2021
Decision Date 08/25/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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