Zepto— 510(k) K170655

Substantially Equivalent

Mynosys Cellular Devices, Inc.

FDA 510(k) clearance K170655 for Zepto, Substantially Equivalent on 2017-06-02. Applicant: Mynosys Cellular Devices, Inc.. Device class: 2.

Clearance details

Applicant: Mynosys Cellular Devices, Inc.
Product code: Code PUL
Device class: Class 2
Regulation: 21 CFR 886.4100
Advisory panel: Ophthalmic
Date received: 2017-03-03
Decision date: 2017-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, 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.