FDA 510(k) Application Details - K020607

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K020607
Device Name	Ventilatory Effort Recorder
Applicant	BIOMEC, INC. 1771 EAST 30TH ST. CLEVELAND, OH 44114-4407 US Other 510(k) Applications for this Company
Contact	TRACEY H WIELINSKI Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	MNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2002
Decision Date	08/30/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review