FDA 510(k) Application Details - K192595

Device Classification Name	Spirometer, Monitoring (W/Wo Alarm)   More FDA Info for this Device
510(K) Number	K192595
Device Name	Spirometer, Monitoring (W/Wo Alarm)
Applicant	Respiratory Motion 80 Coolidge Hill Road Watertown, MA 02472 US Other 510(k) Applications for this Company
Contact	Susan K. Hamann Other 510(k) Applications for this Contact
Regulation Number	868.1850   More FDA Info for this Regulation Number
Classification Product Code	BZK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2019
Decision Date	12/17/2019
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