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FDA 510(k)

REFERENCE & MONITORING ELECTRODE

K-Number: K830600 · 1983-03-24

ApplicantPrecision Cap Systems
Decision Date1983-03-24
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REFERENCE & MONITORING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Precision Cap Systems. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830600. 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 REFERENCE & MONITORING ELECTRODE?

REFERENCE & MONITORING ELECTRODE is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Precision Cap Systems. The 510(k) number is K830600.

When did REFERENCE & MONITORING ELECTRODE receive FDA 510(k) clearance?

REFERENCE & MONITORING ELECTRODE received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830600.

Who is the listed applicant for REFERENCE & MONITORING ELECTRODE?

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

What is the FDA product code for REFERENCE & MONITORING ELECTRODE?

The FDA product code for REFERENCE & MONITORING ELECTRODE is GXY.

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Other records listing Precision Cap Systems 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.

K830602PRECISION CAP STRAPSK830598EVOKED POTENTIAL CAP W/EVOKED POTENTIALK830597BABY CAP, ELECTRODE SET & BOARD ADAPTORK830599LOCALIZING ELECTRODEK830601FOAMIES DIAPOS. FOAM RUBBER PADSK830521PRECISION EEG CAP W/ELECTRODE SET AND

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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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