Smart Scope® CX— 510(k) K233043

Name: FDA 510(k) clearance K233043
Creator: U.S. Food and Drug Administration
Published: 2024-06-14

Substantially Equivalent

Periwinkle Technologies Pvt., Ltd.

FDA 510(k) clearance K233043 for Smart Scope® CX, Substantially Equivalent on 2024-06-14. Applicant: Periwinkle Technologies Pvt., Ltd.. Device class: 2.

Clearance details

Applicant: Periwinkle Technologies Pvt., Ltd.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2023-09-25
Decision date: 2024-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pune, IN

Download summary PDF View on FDA.gov ↗

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