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FDA 510(k)

SKULL BASE INSTATRAK SYSTEM

K-Number: K982994 · 1998-11-16

ApplicantVisualization Technology, Inc.
Decision Date1998-11-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SKULL BASE INSTATRAK SYSTEM 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 1998-11-16 under 510(k) number K982994. 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 SKULL BASE INSTATRAK SYSTEM?

SKULL BASE INSTATRAK SYSTEM is a medical device that received FDA 510(k) clearance on 1998-11-16. The listed applicant is Visualization Technology, Inc.. The 510(k) number is K982994.

When did SKULL BASE INSTATRAK SYSTEM receive FDA 510(k) clearance?

SKULL BASE INSTATRAK SYSTEM received FDA 510(k) clearance on 1998-11-16, under 510(k) number K982994.

Who is the listed applicant for SKULL BASE INSTATRAK SYSTEM?

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 SKULL BASE INSTATRAK SYSTEM?

The FDA product code for SKULL BASE INSTATRAK SYSTEM 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 IT3500K994270INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000K990919STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAGK983529INSTATRAK 3000K981998PEDIATRIC INSTATRAK SYSTEMK960330INSTATRAK

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Related Devices (Code: LLZ)

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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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