FDA 510(k) Application Details - K811980

Device Classification Name Transducer, Blood-Pressure, Extravascular

  More FDA Info for this Device
510(K) Number K811980
Device Name Transducer, Blood-Pressure, Extravascular
Applicant H.R. BIOMEDICAL, LTD.

, US
Other 510(k) Applications for this Company
Regulation Number 870.2850

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

  More FDA Info for this Product Code
Date Received 07/13/1981
Decision Date 07/28/1981
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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