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FDA 510(k)

SnugKap

K-Number: K193383 · 2021-06-07

ApplicantHeadstart, Ltd.
Decision Date2021-06-07
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SnugKap is a medical device manufactured by Headstart, Ltd.. It received FDA 510(k) clearance on 2021-06-07 under approval number K193383. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SnugKap?

SnugKap is a medical device that received FDA 510(k) clearance on 2021-06-07. It is manufactured by Headstart, Ltd.. The 510(k) number is K193383.

When was SnugKap approved by the FDA?

SnugKap received FDA 510(k) clearance on 2021-06-07, under approval number K193383.

What company makes SnugKap?

SnugKap is manufactured by Headstart, Ltd..

What is the FDA product code for SnugKap?

The FDA product code for SnugKap is MVA.

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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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