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FDA 510(k)

DUCKBILL VOICE PROSTHESIS & TRACHEO

K-Number: K832967 · 1983-12-23

ApplicantAmerican V. Mueller
Decision Date1983-12-23
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DUCKBILL VOICE PROSTHESIS & TRACHEO is the device name listed in this FDA 510(k) record. The listed applicant is American V. Mueller. It received FDA 510(k) clearance on 1983-12-23 under 510(k) number K832967. 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 DUCKBILL VOICE PROSTHESIS & TRACHEO?

DUCKBILL VOICE PROSTHESIS & TRACHEO is a medical device that received FDA 510(k) clearance on 1983-12-23. The listed applicant is American V. Mueller. The 510(k) number is K832967.

When did DUCKBILL VOICE PROSTHESIS & TRACHEO receive FDA 510(k) clearance?

DUCKBILL VOICE PROSTHESIS & TRACHEO received FDA 510(k) clearance on 1983-12-23, under 510(k) number K832967.

Who is the listed applicant for DUCKBILL VOICE PROSTHESIS & TRACHEO?

The FDA 510(k) record lists American V. Mueller as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUCKBILL VOICE PROSTHESIS & TRACHEO?

The FDA product code for DUCKBILL VOICE PROSTHESIS & TRACHEO is EWL.

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Other records listing American V. Mueller as applicant

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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.

K240763FirstFit Surgical KitFreudenberg Medical, LLCK131947PROVOX VEGA PUNCTURE SETAtos Medical ABK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical ABK093258BLOM-SINGER INDWELLING TEP OCCLUDERHelix Medical, LLCK090455PROVOX VEGA, MODEL 8130-8135Atos Medical ABK082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESHelix Medical, LLC

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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