DigniCap Scalp Cooling System
K-Number: K170871 · 2017-07-03
ApplicantDignitana AB
Decision Date2017-07-03
Product CodePMC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DigniCap Scalp Cooling System is a medical device manufactured by Dignitana AB. It received FDA 510(k) clearance on 2017-07-03 under approval number K170871. The device is classified under product code PMC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DigniCap Scalp Cooling System?
DigniCap Scalp Cooling System is a medical device that received FDA 510(k) clearance on 2017-07-03. It is manufactured by Dignitana AB. The 510(k) number is K170871.
When was DigniCap Scalp Cooling System approved by the FDA?
DigniCap Scalp Cooling System received FDA 510(k) clearance on 2017-07-03, under approval number K170871.
What company makes DigniCap Scalp Cooling System?
DigniCap Scalp Cooling System is manufactured by Dignitana AB.
What is the FDA product code for DigniCap Scalp Cooling System?
The FDA product code for DigniCap Scalp Cooling System is PMC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.