FDA 510(k) Application Details - K974621

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K974621
Device Name	Plethysmograph, Impedance
Applicant	E-Z-EM, INC. 717 MAIN ST. WESTBURY, NY 11590 US Other 510(k) Applications for this Company
Contact	TERRY ZISOWITZ 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	12/11/1997
Decision Date	01/27/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review