FDA 510(k) Application Details - K190663

Device Classification Name Filter, Conduction, Anesthetic

  More FDA Info for this Device
510(K) Number K190663
Device Name Filter, Conduction, Anesthetic
Applicant Pajunk GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen 78187 DE
Other 510(k) Applications for this Company
Contact Christian G. H. Quass
Other 510(k) Applications for this Contact
Regulation Number 868.5130

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

  More FDA Info for this Product Code
Date Received 03/15/2019
Decision Date 06/17/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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