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FDA 510(k)

LIFESCAN EVOKED POTENTIAL SYSTEM

K-Number: K861900 · 1986-08-25

ApplicantNeurometrics
Decision Date1986-08-25
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFESCAN EVOKED POTENTIAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrics. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K861900. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESCAN EVOKED POTENTIAL SYSTEM?

LIFESCAN EVOKED POTENTIAL SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Neurometrics. The 510(k) number is K861900.

When did LIFESCAN EVOKED POTENTIAL SYSTEM receive FDA 510(k) clearance?

LIFESCAN EVOKED POTENTIAL SYSTEM received FDA 510(k) clearance on 1986-08-25, under 510(k) number K861900.

Who is the listed applicant for LIFESCAN EVOKED POTENTIAL SYSTEM?

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

What is the FDA product code for LIFESCAN EVOKED POTENTIAL SYSTEM?

The FDA product code for LIFESCAN EVOKED POTENTIAL SYSTEM is GWF.

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Other records listing Neurometrics 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.

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Related Devices (Code: GWF)

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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