FDA 510(k) Application Details - K983449

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K983449
Device Name	Monitor, Breathing Frequency
Applicant	GEREONICS, INC. 4650-143 DULIN RD. FALLBROOK, CA 92028 US Other 510(k) Applications for this Company
Contact	GERALD A 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	09/30/1998
Decision Date	02/08/1999
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