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FDA 510(k)

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS

K-Number: K953449 · 1995-10-12

ApplicantPhysiometrix, Inc.
Decision Date1995-10-12
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1995-10-12 under 510(k) number K953449. 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 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS?

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is Physiometrix, Inc.. The 510(k) number is K953449.

When did MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS receive FDA 510(k) clearance?

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS received FDA 510(k) clearance on 1995-10-12, under 510(k) number K953449.

Who is the listed applicant for MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS?

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 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS?

The FDA product code for MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS 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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