FDA 510(k) Application Details - K202480

Device Classification Name	Mixer, Breathing Gases, Anesthesia Inhalation   More FDA Info for this Device
510(K) Number	K202480
Device Name	Mixer, Breathing Gases, Anesthesia Inhalation
Applicant	Parker Hannifin 245 Township Line Road Hatfield, PA 19440 US Other 510(k) Applications for this Company
Contact	Andrew Ellinger Other 510(k) Applications for this Contact
Regulation Number	868.5330   More FDA Info for this Regulation Number
Classification Product Code	BZR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2020
Decision Date	04/22/2021
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	Y
Expedited Review