FDA 510(k) Application Details - K130702

Device Classification Name Cleaner, Air, Medical Recirculating

  More FDA Info for this Device
510(K) Number K130702
Device Name Cleaner, Air, Medical Recirculating
Applicant AIRSONETT, AB
435 RICE CREEK TERRACE NE
FRIDLEY, MN 55432 US
Other 510(k) Applications for this Company
Contact CONSTANCE G BUNDY
Other 510(k) Applications for this Contact
Regulation Number 880.5045

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

  More FDA Info for this Product Code
Date Received 03/15/2013
Decision Date 07/23/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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