FDA 510(k) Application Details - K243225

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K243225
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	Genadyne Biotechnologies, Inc. 16 Midland Ave Hicksville, NY 11801 US Other 510(k) Applications for this Company
Contact	Chien Ming Goh Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2024
Decision Date	12/31/2024
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