FDA 510(k) Application Details - K992413

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K992413
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. ARLETA, CA 91331 US Other 510(k) Applications for this Company
Contact	DAVID M TRUEBLOOD Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/1999
Decision Date	08/19/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review