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FDA 510(k)

ZORTRAN DETECTOR

K-Number: K000997 · 2000-09-07

ApplicantLucent Medical Systems
Decision Date2000-09-07
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZORTRAN DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Lucent Medical Systems. It received FDA 510(k) clearance on 2000-09-07 under 510(k) number K000997. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZORTRAN DETECTOR?

ZORTRAN DETECTOR is a medical device that received FDA 510(k) clearance on 2000-09-07. The listed applicant is Lucent Medical Systems. The 510(k) number is K000997.

When did ZORTRAN DETECTOR receive FDA 510(k) clearance?

ZORTRAN DETECTOR received FDA 510(k) clearance on 2000-09-07, under 510(k) number K000997.

Who is the listed applicant for ZORTRAN DETECTOR?

The FDA 510(k) record lists Lucent Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZORTRAN DETECTOR?

The FDA product code for ZORTRAN DETECTOR is FOZ.

Related Clinical Trials

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Other records listing Lucent Medical Systems 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.

K061240SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES

Related Devices (Code: FOZ)

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

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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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