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FDA 510(k)

BLOM-SINGER VOICE PROSTHESIS

K-Number: K812982 · 1981-11-24

ApplicantBivona Medical Technologies
Decision Date1981-11-24
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER VOICE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K812982. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOM-SINGER VOICE PROSTHESIS?

BLOM-SINGER VOICE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Bivona Medical Technologies. The 510(k) number is K812982.

When did BLOM-SINGER VOICE PROSTHESIS receive FDA 510(k) clearance?

BLOM-SINGER VOICE PROSTHESIS received FDA 510(k) clearance on 1981-11-24, under 510(k) number K812982.

Who is the listed applicant for BLOM-SINGER VOICE PROSTHESIS?

The FDA 510(k) record lists Bivona Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOM-SINGER VOICE PROSTHESIS?

The FDA product code for BLOM-SINGER VOICE PROSTHESIS is EWL.

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Related Devices (Code: EWL)

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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