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FDA 510(k)

Shoulder PacemakerTM

K-Number: K220994 · 2022-10-14

ApplicantNcs Lab Srl
Decision Date2022-10-14
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Shoulder PacemakerTM is a medical device manufactured by Ncs Lab Srl. It received FDA 510(k) clearance on 2022-10-14 under approval number K220994. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shoulder PacemakerTM?

Shoulder PacemakerTM is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Ncs Lab Srl. The 510(k) number is K220994.

When was Shoulder PacemakerTM approved by the FDA?

Shoulder PacemakerTM received FDA 510(k) clearance on 2022-10-14, under approval number K220994.

What company makes Shoulder PacemakerTM?

Shoulder PacemakerTM is manufactured by Ncs Lab Srl.

What is the FDA product code for Shoulder PacemakerTM?

The FDA product code for Shoulder PacemakerTM is IPF.

Other Devices by Ncs Lab Srl

K160500Elite SPK, Compasso, Elite SPK Kit K210674Shoulder Pacemaker

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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