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FDA 510(k)

NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

K-Number: K013419 · 2001-12-20

ApplicantNicolet Biomedical
Decision Date2001-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K013419. 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 NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM?

NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Nicolet Biomedical. The 510(k) number is K013419.

When did NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM receive FDA 510(k) clearance?

NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM received FDA 510(k) clearance on 2001-12-20, under 510(k) number K013419.

Who is the listed applicant for NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM?

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

What is the FDA product code for NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM?

The FDA product code for NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM is LLZ.

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Other records listing Nicolet Biomedical 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.

K020754NICOLET PIONEER TC8080K013281VERSALAB APMK011135GSI AUDERAK010521NICOLET VERSALABK002766NICOLET VASOGUARDK993939NICOLET EME LEGEND TC22

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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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