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FDA 510(k)

EMITENS ELECTRODES

K-Number: K922393 · 1993-07-21

ApplicantElectronic Monitors, Inc.
Decision Date1993-07-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMITENS ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Monitors, Inc.. It received FDA 510(k) clearance on 1993-07-21 under 510(k) number K922393. 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 EMITENS ELECTRODES?

EMITENS ELECTRODES is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is Electronic Monitors, Inc.. The 510(k) number is K922393.

When did EMITENS ELECTRODES receive FDA 510(k) clearance?

EMITENS ELECTRODES received FDA 510(k) clearance on 1993-07-21, under 510(k) number K922393.

Who is the listed applicant for EMITENS ELECTRODES?

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

What is the FDA product code for EMITENS ELECTRODES?

The FDA product code for EMITENS ELECTRODES is GXY.

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Other records listing Electronic Monitors, Inc. 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: GXY)

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Official Source

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