Shoulder Pacemaker— 510(k) K210674

Substantially Equivalent

Ncs Lab Srl

FDA 510(k) clearance K210674 for Shoulder Pacemaker, Substantially Equivalent on 2021-08-24. Applicant: Ncs Lab Srl. Device class: 2.

Clearance details

Applicant: Ncs Lab Srl
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2021-03-05
Decision date: 2021-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpi, IT

Download summary PDF View on FDA.gov ↗

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More clearances from Ncs Lab Srl

K220994 — Shoulder PacemakerTM2022-10-14
K160500 — Elite SPK, Compasso, Elite SPK Kit2016-04-20
K120356 — NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD2012-12-11

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