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FDA 510(k)

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

K-Number: K970942 · 1997-06-02

ApplicantPhysiometrix, Inc.
Decision Date1997-06-02
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1997-06-02 under 510(k) number K970942. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM?

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-02. The listed applicant is Physiometrix, Inc.. The 510(k) number is K970942.

When did MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM receive FDA 510(k) clearance?

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM received FDA 510(k) clearance on 1997-06-02, under 510(k) number K970942.

Who is the listed applicant for MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM?

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

What is the FDA product code for MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM?

The FDA product code for MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM is GWQ.

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Related Devices (Code: GWQ)

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

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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