FDA 510(k) Application Details - K130570

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K130570
Device Name	Monitor, Breathing Frequency
Applicant	NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	CHRISTINE VERGELY 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	03/04/2013
Decision Date	12/26/2013
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