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FDA 510(k)

ARTEMIS

K-Number: K021333 · 2002-10-08

ApplicantUltralink, LLC
Decision Date2002-10-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTEMIS is the device name listed in this FDA 510(k) record. The listed applicant is Ultralink, LLC. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K021333. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTEMIS?

ARTEMIS is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Ultralink, LLC. The 510(k) number is K021333.

When did ARTEMIS receive FDA 510(k) clearance?

ARTEMIS received FDA 510(k) clearance on 2002-10-08, under 510(k) number K021333.

Who is the listed applicant for ARTEMIS?

The FDA 510(k) record lists Ultralink, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTEMIS?

The FDA product code for ARTEMIS is IYO.

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Other records listing Ultralink, LLC 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.

K003890VHF ULTRASONIC ARC-SCAN SYSTEM

Related Devices (Code: IYO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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