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FDA 510(k)

ERG-JET ELECTRODE

K-Number: K823767 · 1983-01-08

ApplicantLife-Tech Intl., Inc.
Decision Date1983-01-08
Product CodeHLF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ERG-JET ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1983-01-08 under 510(k) number K823767. The device is classified under product code HLF. 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 1983-01-08. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K823767.

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

ERG-JET ELECTRODE received FDA 510(k) clearance on 1983-01-08, under 510(k) number K823767.

Who is the listed applicant for ERG-JET ELECTRODE?

The FDA 510(k) record lists Life-Tech Intl., Inc. 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 HLF.

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Other records listing Life-Tech Intl., Inc. as applicant

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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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