FDA 510(k) Application Details - K961138

Device Classification Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)   More FDA Info for this Device
510(K) Number	K961138
Device Name	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant	MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. ARLETA, CA 91331 US Other 510(k) Applications for this Company
Contact	DAVID M TRUBLOOD Other 510(k) Applications for this Contact
Regulation Number	870.5550   More FDA Info for this Regulation Number
Classification Product Code	DRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/1996
Decision Date	12/10/1996
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