FDA 510(k) Application Details - K240271

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K240271
Device Name	Monitor, Breathing Frequency
Applicant	Linshom Medical Inc. 2922 Excelsior Springs Court Ellicott City, MD 21042 US Other 510(k) Applications for this Company
Contact	William Stoll 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	01/31/2024
Decision Date	09/11/2024
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