FDA 510(k) Application Details - K243236

Device Classification Name	More FDA Info for this Device
510(K) Number	K243236
Device Name	WHOOP ECG (electrocardiogram) Feature (1.0)
Applicant	Whoop, Inc. One Kenmore Sq Boston, MA 02215 US Other 510(k) Applications for this Company
Contact	Nikki Batista Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2024
Decision Date	04/04/2025
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