FDA 510(k)

DigniCap Delta

K-Number: K191166 · 2019-06-26

Decision Date2019-06-26

Product CodePMC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DigniCap Delta is the device name listed in this FDA 510(k) record. The listed applicant is Dignitana, Inc.. It received FDA 510(k) clearance on 2019-06-26 under 510(k) number K191166. 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 Delta?

DigniCap Delta is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Dignitana, Inc.. The 510(k) number is K191166.

When did DigniCap Delta receive FDA 510(k) clearance?

DigniCap Delta received FDA 510(k) clearance on 2019-06-26, under 510(k) number K191166.

Who is the listed applicant for DigniCap Delta?

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

What is the FDA product code for DigniCap Delta?

The FDA product code for DigniCap Delta 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 Limited K211526Portable Scalp Cooling SystemCooler Heads Care, Inc.K173032Paxman Scalp CoolerPaxman Coolers Limited K170871DigniCap Scalp Cooling SystemDignitana AB K163484Paxman 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.