FDA 510(k) Application Details - K243861

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K243861
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	Compact Medical, Inc. 525 South Meridian St. Suite 2D2 Indianapolis, IN 46259 US Other 510(k) Applications for this Company
Contact	Jonathan Merrell Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2024
Decision Date	04/25/2025
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