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FDA 510(k)

Life Scope PT BSM-1700 Series Bedside Monitor

K-Number: K220976 · 2022-07-21

Decision Date2022-07-21
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Life Scope PT BSM-1700 Series Bedside Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K220976. 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 Life Scope PT BSM-1700 Series Bedside Monitor?

Life Scope PT BSM-1700 Series Bedside Monitor is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K220976.

When did Life Scope PT BSM-1700 Series Bedside Monitor receive FDA 510(k) clearance?

Life Scope PT BSM-1700 Series Bedside Monitor received FDA 510(k) clearance on 2022-07-21, under 510(k) number K220976.

Who is the listed applicant for Life Scope PT BSM-1700 Series Bedside Monitor?

The FDA 510(k) record lists Nihon Kohden Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Life Scope PT BSM-1700 Series Bedside Monitor?

The FDA product code for Life Scope PT BSM-1700 Series Bedside Monitor is KOI.

Other records listing Nihon Kohden Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 19 devices →

Related Devices (Code: KOI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.