FDA 510(k) Application Details - K970368

Device Classification Name Oximeter

  More FDA Info for this Device
510(K) Number K970368
Device Name Oximeter
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact JAQUELINE EMERY
Other 510(k) Applications for this Contact
Regulation Number 870.2700

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

  More FDA Info for this Product Code
Date Received 01/31/1997
Decision Date 05/06/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
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