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FDA 510(k)

MODEL 1220, OR E-NET (54-62 CM)

K-Number: K961609 · 1996-05-10

ApplicantPhysiometrix, Inc.
Decision Date1996-05-10
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 1220, OR E-NET (54-62 CM) is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1996-05-10 under 510(k) number K961609. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1220, OR E-NET (54-62 CM)?

MODEL 1220, OR E-NET (54-62 CM) is a medical device that received FDA 510(k) clearance on 1996-05-10. The listed applicant is Physiometrix, Inc.. The 510(k) number is K961609.

When did MODEL 1220, OR E-NET (54-62 CM) receive FDA 510(k) clearance?

MODEL 1220, OR E-NET (54-62 CM) received FDA 510(k) clearance on 1996-05-10, under 510(k) number K961609.

Who is the listed applicant for MODEL 1220, OR E-NET (54-62 CM)?

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 1220, OR E-NET (54-62 CM)?

The FDA product code for MODEL 1220, OR E-NET (54-62 CM) is GXY.

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Other records listing Physiometrix, Inc. as applicant

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Related Devices (Code: GXY)

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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