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FDA 510(k)

DigniCap Delta

K-Number: K191166 · 2019-06-26

ApplicantDignitana, Inc.
Decision Date2019-06-26
Product CodePMC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DigniCap Delta is a medical device manufactured by Dignitana, Inc.. It received FDA 510(k) clearance on 2019-06-26 under approval 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. It is manufactured by Dignitana, Inc.. The 510(k) number is K191166.

When was DigniCap Delta approved by the FDA?

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

What company makes DigniCap Delta?

DigniCap Delta is manufactured by Dignitana, Inc..

What is the FDA product code for DigniCap Delta?

The FDA product code for DigniCap Delta 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.

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