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FDA 510(k)

BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS

K-Number: K861088 · 1986-04-02

ApplicantBivona Medical Technologies
Decision Date1986-04-02
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIVONA ECONOMY DUCKBILL 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 1986-04-02 under 510(k) number K861088. 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 BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS?

BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1986-04-02. The listed applicant is Bivona Medical Technologies. The 510(k) number is K861088.

When did BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS receive FDA 510(k) clearance?

BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS received FDA 510(k) clearance on 1986-04-02, under 510(k) number K861088.

Who is the listed applicant for BIVONA ECONOMY DUCKBILL 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 BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS?

The FDA product code for BIVONA ECONOMY DUCKBILL 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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