FDA 510(k) Application Details - K072449

Device Classification Name Electrocardiograph

  More FDA Info for this Device
510(K) Number K072449
Device Name Electrocardiograph
Applicant WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
Other 510(k) Applications for this Company
Contact JOHN SAWYER
Other 510(k) Applications for this Contact
Regulation Number 870.2340

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

  More FDA Info for this Product Code
Date Received 08/31/2007
Decision Date 11/29/2007
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