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FDA 510(k)

ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM

K-Number: K901503 · 1990-06-28

ApplicantStanton Magnetics, Inc.
Decision Date1990-06-28
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stanton Magnetics, Inc.. It received FDA 510(k) clearance on 1990-06-28 under 510(k) number K901503. The device is classified under product code ESE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM?

ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Stanton Magnetics, Inc.. The 510(k) number is K901503.

When did ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM receive FDA 510(k) clearance?

ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM received FDA 510(k) clearance on 1990-06-28, under 510(k) number K901503.

Who is the listed applicant for ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM?

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

What is the FDA product code for ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM?

The FDA product code for ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM is ESE.

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Related Devices (Code: ESE)

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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