FDA 510(k) Application Details - K100773

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K100773
Device Name	Monitor, Breathing Frequency
Applicant	KAI MEDICAL, INC. 3465 WAIALAE AVE SUITE 370 HONOLULU, HI 96816 US Other 510(k) Applications for this Company
Contact	ROBERT NAKATA 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	03/18/2010
Decision Date	06/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review