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FDA 510(k)

LIFESCOPE II/FOUR

K-Number: K823249 · 1982-11-24

ApplicantNihon Kohden America, Inc.
Decision Date1982-11-24
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFESCOPE II/FOUR is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1982-11-24 under 510(k) number K823249. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESCOPE II/FOUR?

LIFESCOPE II/FOUR is a medical device that received FDA 510(k) clearance on 1982-11-24. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K823249.

When did LIFESCOPE II/FOUR receive FDA 510(k) clearance?

LIFESCOPE II/FOUR received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823249.

Who is the listed applicant for LIFESCOPE II/FOUR?

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

What is the FDA product code for LIFESCOPE II/FOUR?

The FDA product code for LIFESCOPE II/FOUR is DRG.

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Other records listing Nihon Kohden America, Inc. 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.

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Related Devices (Code: DRG)

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.

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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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