FDA 510(k) Application Details - K211289

Device Classification Name	Compressor, Cardiac, External   More FDA Info for this Device
510(K) Number	K211289
Device Name	Compressor, Cardiac, External
Applicant	Defibtech, LLC 741 Boston Post Road Guilford, CT 06437 US Other 510(k) Applications for this Company
Contact	Allison Bohren Other 510(k) Applications for this Contact
Regulation Number	870.5200   More FDA Info for this Regulation Number
Classification Product Code	DRM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2021
Decision Date	11/09/2021
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