FDA 510(k) Application Details - K001579

Device Classification Name Conserver, Oxygen

  More FDA Info for this Device
510(K) Number K001579
Device Name Conserver, Oxygen
Applicant AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO, NY 14228 US
Other 510(k) Applications for this Company
Contact JAMES A ALESSI
Other 510(k) Applications for this Contact
Regulation Number 868.5905

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

  More FDA Info for this Product Code
Date Received 05/22/2000
Decision Date 08/31/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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