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FDA 510(k)

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series

K-Number: K201949 · 2021-05-02

ApplicantNihon Kohden Corporation
Decision Date2021-05-02
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series is a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2021-05-02 under approval number K201949. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series is a medical device that received FDA 510(k) clearance on 2021-05-02. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K201949.

When was Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series approved by the FDA?

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series received FDA 510(k) clearance on 2021-05-02, under approval number K201949.

What company makes Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series is manufactured by Nihon Kohden Corporation.

What is the FDA product code for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series?

The FDA product code for Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series is KOI.

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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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