Apyx— 510(k) K213783

Substantially Equivalent

Escala Medical

FDA 510(k) clearance K213783 for Apyx, Substantially Equivalent on 2022-04-05. Applicant: Escala Medical. Device class: 2.

Clearance details

Applicant: Escala Medical
Product code: Code PBQ
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2021-12-03
Decision date: 2022-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Misgav Industrial Park, IL

Download summary PDF View on FDA.gov ↗

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