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FDA 510(k)

INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000

K-Number: K994270 · 2000-03-09

ApplicantVisualization Technology, Inc.
Decision Date2000-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 is the device name listed in this FDA 510(k) record. The listed applicant is Visualization Technology, Inc.. It received FDA 510(k) clearance on 2000-03-09 under 510(k) number K994270. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000?

INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 is a medical device that received FDA 510(k) clearance on 2000-03-09. The listed applicant is Visualization Technology, Inc.. The 510(k) number is K994270.

When did INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 receive FDA 510(k) clearance?

INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 received FDA 510(k) clearance on 2000-03-09, under 510(k) number K994270.

Who is the listed applicant for INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000?

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

What is the FDA product code for INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000?

The FDA product code for INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 is LLZ.

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Other records listing Visualization Technology, 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.

K003510INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500K990919STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAGK983529INSTATRAK 3000K982994SKULL BASE INSTATRAK SYSTEMK981998PEDIATRIC INSTATRAK SYSTEMK960330INSTATRAK

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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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