FDA 510(k) Application Details - K242001

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K242001
Device Name	Monitor, Breathing Frequency
Applicant	Philips Medical Systems Nederland B.V. High Tech Campus 34 Eindhoven 5656 AE NL Other 510(k) Applications for this Company
Contact	David Boser 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	07/09/2024
Decision Date	04/04/2025
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