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FDA 510(k)

VOICE MASTER PROSTHESIS

K-Number: K974132 · 1998-02-25

ApplicantE. Benson Hood Lab, Inc.
Decision Date1998-02-25
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOICE MASTER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is E. Benson Hood Lab, Inc.. It received FDA 510(k) clearance on 1998-02-25 under 510(k) number K974132. 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 VOICE MASTER PROSTHESIS?

VOICE MASTER PROSTHESIS is a medical device that received FDA 510(k) clearance on 1998-02-25. The listed applicant is E. Benson Hood Lab, Inc.. The 510(k) number is K974132.

When did VOICE MASTER PROSTHESIS receive FDA 510(k) clearance?

VOICE MASTER PROSTHESIS received FDA 510(k) clearance on 1998-02-25, under 510(k) number K974132.

Who is the listed applicant for VOICE MASTER PROSTHESIS?

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

What is the FDA product code for VOICE MASTER PROSTHESIS?

The FDA product code for VOICE MASTER PROSTHESIS is EWL.

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Other records listing E. Benson Hood Lab, 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.

K011329ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETERK000154ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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