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FDA 510(k)

BEHIND-THE-EAR MASKING AMPLIFIER,735S

K-Number: K780546 · 1978-04-10

ApplicantDanavox, Inc.
Decision Date1978-04-10
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND-THE-EAR MASKING AMPLIFIER,735S is the device name listed in this FDA 510(k) record. The listed applicant is Danavox, Inc.. It received FDA 510(k) clearance on 1978-04-10 under 510(k) number K780546. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEHIND-THE-EAR MASKING AMPLIFIER,735S?

BEHIND-THE-EAR MASKING AMPLIFIER,735S is a medical device that received FDA 510(k) clearance on 1978-04-10. The listed applicant is Danavox, Inc.. The 510(k) number is K780546.

When did BEHIND-THE-EAR MASKING AMPLIFIER,735S receive FDA 510(k) clearance?

BEHIND-THE-EAR MASKING AMPLIFIER,735S received FDA 510(k) clearance on 1978-04-10, under 510(k) number K780546.

Who is the listed applicant for BEHIND-THE-EAR MASKING AMPLIFIER,735S?

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

What is the FDA product code for BEHIND-THE-EAR MASKING AMPLIFIER,735S?

The FDA product code for BEHIND-THE-EAR MASKING AMPLIFIER,735S is KLW.

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Other records listing Danavox, 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.

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Related Devices (Code: KLW)

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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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