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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 the device name listed in this FDA 510(k) record. The listed applicant is Headstart, Ltd.. It received FDA 510(k) clearance on 2021-06-07 under 510(k) 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. The listed applicant is Headstart, Ltd.. The 510(k) number is K193383.

When did SnugKap receive FDA 510(k) clearance?

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

Who is the listed applicant for SnugKap?

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

What is the FDA product code for SnugKap?

The FDA product code for SnugKap is MVA.

Related Devices (Code: MVA)

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.

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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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