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FDA 510(k)

FLUOROLAB PLUS

K-Number: K002893 · 2000-12-04

ApplicantZ-Kat, Inc.
Decision Date2000-12-04
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FLUOROLAB PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Z-Kat, Inc.. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K002893. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROLAB PLUS?

FLUOROLAB PLUS is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is Z-Kat, Inc.. The 510(k) number is K002893.

When did FLUOROLAB PLUS receive FDA 510(k) clearance?

FLUOROLAB PLUS received FDA 510(k) clearance on 2000-12-04, under 510(k) number K002893.

Who is the listed applicant for FLUOROLAB PLUS?

The FDA 510(k) record lists Z-Kat, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUOROLAB PLUS?

The FDA product code for FLUOROLAB PLUS is HAW.

Related Clinical Trials

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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Other records listing Z-Kat, 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.

K030764Z-BOXK023975VOYAGER LINUXK013025MODIFICATION TO FLOUROLAB PLUSK984298Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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