CT3000Pro— 510(k) K212830

Substantially Equivalent

Srs Medical

FDA 510(k) clearance K212830 for CT3000Pro, Substantially Equivalent on 2021-12-21. Applicant: Srs Medical. Device class: 2.

Clearance details

Applicant: Srs Medical
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-07
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Billerica, MA, 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.