FDA 510(k) Application Details - K102723

Device Classification Name Electrocardiograph,Ambulatory(Without Analysis)

  More FDA Info for this Device
510(K) Number K102723
Device Name Electrocardiograph,Ambulatory(Without Analysis)
Applicant MEMTEC CORP.
68 STILES RD. UNIT D
SALEM, NH 03079 US
Other 510(k) Applications for this Company
Contact DENNIS GARBOSKI
Other 510(k) Applications for this Contact
Regulation Number 870.2800

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

  More FDA Info for this Product Code
Date Received 09/21/2010
Decision Date 12/09/2010
Decision SESE - SUBST EQUIV
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