FDA 510(k) Application Details - K021174

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K021174
Device Name	Plethysmograph, Impedance
Applicant	IMAGYN SURGICAL 8850 M-89 RICHLAND, MI 49083 US Other 510(k) Applications for this Company
Contact	JULIE POWELL Other 510(k) Applications for this Contact
Regulation Number	870.2770   More FDA Info for this Regulation Number
Classification Product Code	DSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2002
Decision Date	04/29/2003
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review