FDA 510(k) Application Details - K211387

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K211387
Device Name	Monitor, Breathing Frequency
Applicant	Sound Life Sciences, Inc. Startup Hall, Box 354625, 1100 NE Campus Parkway, Suite 200 Seattle, WA 98195-4625 US Other 510(k) Applications for this Company
Contact	Kamal Shah 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	05/05/2021
Decision Date	11/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review