SnugKap— 510(k) K193383

Substantially Equivalent

Headstart, Ltd.

FDA 510(k) clearance K193383 for SnugKap, Substantially Equivalent on 2021-06-07. Applicant: Headstart, Ltd.. Device class: 2.

Clearance details

Applicant: Headstart, Ltd.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2019-12-05
Decision date: 2021-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.