FDA 510(k) Application Details - K232021

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K232021
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhongyuan Road Suzhou Industrial Park Suzhou 215024 CN Other 510(k) Applications for this Company
Contact	Li Sherry Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2023
Decision Date	09/01/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review