FDA 510(k) Application Details - K102377

Device Classification Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   More FDA Info for this Device
510(K) Number	K102377
Device Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant	A PLUS MEDICAL 5431 AVENIDA ENCINAS SUITE G CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	THOMAS C LOESCHER Other 510(k) Applications for this Contact
Regulation Number	868.2600   More FDA Info for this Regulation Number
Classification Product Code	CAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2010
Decision Date	11/18/2010
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