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FDA 510(k)

ARTOS, DIPLOS SYSTEM

K-Number: K970284 · 1997-04-21

ApplicantTurnkey Intergration USA, Inc.
Decision Date1997-04-21
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTOS, DIPLOS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K970284. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTOS, DIPLOS SYSTEM?

ARTOS, DIPLOS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K970284.

When did ARTOS, DIPLOS SYSTEM receive FDA 510(k) clearance?

ARTOS, DIPLOS SYSTEM received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970284.

Who is the listed applicant for ARTOS, DIPLOS SYSTEM?

The FDA 510(k) record lists Turnkey Intergration USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTOS, DIPLOS SYSTEM?

The FDA product code for ARTOS, DIPLOS SYSTEM is KWY.

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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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