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FDA 510(k)

ERG-JET ELECTRODE

K-Number: K830557 · 1983-03-31

ApplicantUniverso S.A.
Decision Date1983-03-31
Product CodeHLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ERG-JET ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Universo S.A.. It received FDA 510(k) clearance on 1983-03-31 under 510(k) number K830557. The device is classified under product code HLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERG-JET ELECTRODE?

ERG-JET ELECTRODE is a medical device that received FDA 510(k) clearance on 1983-03-31. The listed applicant is Universo S.A.. The 510(k) number is K830557.

When did ERG-JET ELECTRODE receive FDA 510(k) clearance?

ERG-JET ELECTRODE received FDA 510(k) clearance on 1983-03-31, under 510(k) number K830557.

Who is the listed applicant for ERG-JET ELECTRODE?

The FDA 510(k) record lists Universo S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERG-JET ELECTRODE?

The FDA product code for ERG-JET ELECTRODE is HLZ.

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Related Devices (Code: HLZ)

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.

K253586RM Electrode (RMH 25-01)Retmap, Inc.K232273RM Electrode (RMH 23-01)Retmap, Inc.K961805TOMEY DTL ELECTRODETomey Corporation USAK926540SOPHER AND BIERER OVUM FORCEPSThomasville Medical Assoc.K913239GOLDLENS(TM)Doran Instruments, Inc.K844409DTL ELECTRODESauquoit Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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