FDA 510(k) Application Details - K961368

Device Classification Name Probe, Blood-Flow, Extravascular

  More FDA Info for this Device
510(K) Number K961368
Device Name Probe, Blood-Flow, Extravascular
Applicant VASAMEDICS, L.L.C.
2963 YORKTON BLVD.
SAINT PAUL, MN 55117-1064 US
Other 510(k) Applications for this Company
Contact DOUGLAS G TOMASKO
Other 510(k) Applications for this Contact
Regulation Number 870.2120

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

  More FDA Info for this Product Code
Date Received 04/09/1996
Decision Date 10/11/1996
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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