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FDA 510(k)

GEN PROFILER SYSTEM

K-Number: K851619 · 1985-05-14

ApplicantElectro-Cucleonics, Inc.
Decision Date1985-05-14
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEN PROFILER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Cucleonics, Inc.. It received FDA 510(k) clearance on 1985-05-14 under 510(k) number K851619. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN PROFILER SYSTEM?

GEN PROFILER SYSTEM is a medical device that received FDA 510(k) clearance on 1985-05-14. The listed applicant is Electro-Cucleonics, Inc.. The 510(k) number is K851619.

When did GEN PROFILER SYSTEM receive FDA 510(k) clearance?

GEN PROFILER SYSTEM received FDA 510(k) clearance on 1985-05-14, under 510(k) number K851619.

Who is the listed applicant for GEN PROFILER SYSTEM?

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

What is the FDA product code for GEN PROFILER SYSTEM?

The FDA product code for GEN PROFILER SYSTEM is JJG.

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Related Devices (Code: JJG)

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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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