510(k) Report

Devices descending from K170871

2 later devices reach DigniCap Scalp Cooling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191166DigniCap DeltaDignitana, Inc.201911
+2K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited20250—