EndoStream(TM)— 510(k) K181457

Substantially Equivalent

Partnership Medical Limited

FDA 510(k) clearance K181457 for EndoStream(TM), Substantially Equivalent on 2019-07-11. Applicant: Partnership Medical Limited. Device class: 2.

Clearance details

Applicant: Partnership Medical Limited
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-04
Decision date: 2019-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fenton, GB

Download summary PDF View on FDA.gov ↗

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