FDA 510(k) Application Details - K963415

Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase

  More FDA Info for this Device
510(K) Number K963415
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant VENTREX, LLC.
159 GIBRALTAR RD.
HORSHAM, PA 19044 US
Other 510(k) Applications for this Company
Contact MARY HUEGEL
Other 510(k) Applications for this Contact
Regulation Number 868.1720

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

  More FDA Info for this Product Code
Date Received 08/30/1996
Decision Date 11/25/1996
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