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FDA 510(k)

LIFESCOPE 8 DEC-8108A AND DEC-8204A

K-Number: K852270 · 1985-07-30

ApplicantNihon Kohden America, Inc.
Decision Date1985-07-30
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFESCOPE 8 DEC-8108A AND DEC-8204A 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 1985-07-30 under 510(k) number K852270. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESCOPE 8 DEC-8108A AND DEC-8204A?

LIFESCOPE 8 DEC-8108A AND DEC-8204A is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K852270.

When did LIFESCOPE 8 DEC-8108A AND DEC-8204A receive FDA 510(k) clearance?

LIFESCOPE 8 DEC-8108A AND DEC-8204A received FDA 510(k) clearance on 1985-07-30, under 510(k) number K852270.

Who is the listed applicant for LIFESCOPE 8 DEC-8108A AND DEC-8204A?

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 8 DEC-8108A AND DEC-8204A?

The FDA product code for LIFESCOPE 8 DEC-8108A AND DEC-8204A is DSI.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: DSI)

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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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