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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dignitana AB. It received FDA 510(k) clearance on 2017-07-03 under 510(k) 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. The listed applicant is Dignitana AB. The 510(k) number is K170871.

When did DigniCap Scalp Cooling System receive FDA 510(k) clearance?

DigniCap Scalp Cooling System received FDA 510(k) clearance on 2017-07-03, under 510(k) number K170871.

Who is the listed applicant for DigniCap Scalp Cooling System?

The FDA 510(k) record lists Dignitana AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DigniCap Scalp Cooling System?

The FDA product code for DigniCap Scalp Cooling System is PMC.

Related Devices (Code: PMC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252289Eva Scalp Cooling SystemStemtech Medical Devices Private LimitedK211526Portable Scalp Cooling SystemCooler Heads Care, Inc.K191166DigniCap DeltaDignitana, Inc.K173032Paxman Scalp CoolerPaxman Coolers LimitedK163484Paxman Scalp CoolerPaxman Coolers Limited

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.

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