FDA 510(k) Application Details - K990027

Device Classification Name Recorder, Magnetic Tape, Medical

  More FDA Info for this Device
510(K) Number K990027
Device Name Recorder, Magnetic Tape, Medical
Applicant DEL MAR AVIONICS
1621 ALTON PKWY.
IRVINE, CA 92606-4801 US
Other 510(k) Applications for this Company
Contact RAPHAEL HENKIN
Other 510(k) Applications for this Contact
Regulation Number 870.2800

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

  More FDA Info for this Product Code
Date Received 01/05/1999
Decision Date 02/09/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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