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FDA 510(k)

GOLD K AMP ULTRA MINI CANAL

K-Number: K950459 · 1995-03-24

ApplicantElectone, Inc.
Decision Date1995-03-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GOLD K AMP ULTRA MINI CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K950459. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLD K AMP ULTRA MINI CANAL?

GOLD K AMP ULTRA MINI CANAL is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Electone, Inc.. The 510(k) number is K950459.

When did GOLD K AMP ULTRA MINI CANAL receive FDA 510(k) clearance?

GOLD K AMP ULTRA MINI CANAL received FDA 510(k) clearance on 1995-03-24, under 510(k) number K950459.

Who is the listed applicant for GOLD K AMP ULTRA MINI CANAL?

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

What is the FDA product code for GOLD K AMP ULTRA MINI CANAL?

The FDA product code for GOLD K AMP ULTRA MINI CANAL is ESD.

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Other records listing Electone, 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.

K973266Z DEQ-IIK961084AM 400K955702SONATA U-01K953050Z33K953047Z20K953051Z35

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Related Devices (Code: ESD)

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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