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FDA 510(k)

BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS

K-Number: K881011 · 1988-05-13

ApplicantBivona Medical Technologies
Decision Date1988-05-13
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIVONA ULTRA LOW RESISTANCE 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 1988-05-13 under 510(k) number K881011. 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 ULTRA LOW RESISTANCE VOICE PROSTHESIS?

BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Bivona Medical Technologies. The 510(k) number is K881011.

When did BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS receive FDA 510(k) clearance?

BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS received FDA 510(k) clearance on 1988-05-13, under 510(k) number K881011.

Who is the listed applicant for BIVONA ULTRA LOW RESISTANCE 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 ULTRA LOW RESISTANCE VOICE PROSTHESIS?

The FDA product code for BIVONA ULTRA LOW RESISTANCE 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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