FDA 510(k) Application Details - K203209

Device Classification Name	Percussor, Powered-Electric   More FDA Info for this Device
510(K) Number	K203209
Device Name	Percussor, Powered-Electric
Applicant	AirPhysio Pty Ltd Unit 1, 43 Greenway Drive Tweed Heads South NSW 2486 AU Other 510(k) Applications for this Company
Contact	Paul OÆBrien Other 510(k) Applications for this Contact
Regulation Number	868.5665   More FDA Info for this Regulation Number
Classification Product Code	BYI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2020
Decision Date	01/15/2021
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