FDA 510(k) Application Details - K011046

Device Classification Name	Compressor, Cardiac, External   More FDA Info for this Device
510(K) Number	K011046
Device Name	Compressor, Cardiac, External
Applicant	REVIVANT CORP. 775 PALOMAR SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	BOB KATZ Other 510(k) Applications for this Contact
Regulation Number	870.5200   More FDA Info for this Regulation Number
Classification Product Code	DRM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2001
Decision Date	10/25/2001
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