FDA 510(k) Application Details - K944180

Device Classification Name Recorder, Magnetic Tape, Medical

  More FDA Info for this Device
510(K) Number K944180
Device Name Recorder, Magnetic Tape, Medical
Applicant MEMTEC CORP.
19B KEEWAYDIN DR.
SALEM, NH 03079 US
Other 510(k) Applications for this Company
Contact HAROLD A SANFORD
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 08/26/1994
Decision Date 03/07/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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