RM4 Control Unit— 510(k) K211224

Substantially Equivalent

Institut Georges Lopez

FDA 510(k) clearance K211224 for RM4 Control Unit, Substantially Equivalent on 2021-10-15. Applicant: Institut Georges Lopez. Device class: 2.

Clearance details

Applicant: Institut Georges Lopez
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2021-04-23
Decision date: 2021-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lissieu, FR

Download summary PDF View on FDA.gov ↗

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