FDA 510(k) Applications for Medical Device Product Code: PMC ()

FDA 510(k) Applications for Medical Device Product Code "PMC"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K211526	Cooler Heads Care, Inc.	Portable Scalp Cooling System	10/21/2021
K170871	Dignitana AB	DigniCap Scalp Cooling System	07/03/2017
DEN150010	DIGNITANA AB	Dignitana AB DigniCap System	12/08/2015
K191166	Dignitana Inc.	DigniCap Delta	06/26/2019
K163484	Paxman Coolers Limited	Paxman Scalp Cooler	04/17/2017
K173032	Paxman Coolers Limited	Paxman Scalp Cooler	06/07/2018