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FDA 510(k)

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS

K-Number: K991587 · 1999-06-25

ApplicantHelix Medical, Inc.
Decision Date1999-06-25
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, Inc.. It received FDA 510(k) clearance on 1999-06-25 under 510(k) number K991587. 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 INDWELLING 2000 VOICE PROSTHESIS?

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1999-06-25. The listed applicant is Helix Medical, Inc.. The 510(k) number is K991587.

When did BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS receive FDA 510(k) clearance?

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS received FDA 510(k) clearance on 1999-06-25, under 510(k) number K991587.

Who is the listed applicant for BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS?

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

What is the FDA product code for BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS?

The FDA product code for BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS is EWL.

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Other records listing Helix Medical, Inc. 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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