FDA 510(k) Application Details - K062883

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K062883
Device Name	Monitor, Breathing Frequency
Applicant	GEREONICS, INC. 244 LA BARRANCA DRIVE SOLANA BEACH, CA 92075 US Other 510(k) Applications for this Company
Contact	GERALD ROST Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	BZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2006
Decision Date	06/13/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review