FDA 510(k) Application Details - K001030

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K001030
Device Name	Monitor, Breathing Frequency
Applicant	DYMEDIX, INC. 800 LEVANGER LN. STOUGHTON, WI 53589 US Other 510(k) Applications for this Company
Contact	Gary Syring 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	03/30/2000
Decision Date	05/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review