FDA 510(k) Application Details - K230145

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K230145
Device Name	Blood Pressure Cuff
Applicant	GE Medical Systems Information Technologies, Inc. 9900 W Innovation Dr. Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Jennifer Strauther Other 510(k) Applications for this Contact
Regulation Number	870.1120   More FDA Info for this Regulation Number
Classification Product Code	DXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2023
Decision Date	03/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review