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FDA 510(k)

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

K-Number: K082206 · 2008-09-04

ApplicantHelix Medical, LLC
Decision Date2008-09-04
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, LLC. It received FDA 510(k) clearance on 2008-09-04 under 510(k) number K082206. 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 DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES?

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES is a medical device that received FDA 510(k) clearance on 2008-09-04. The listed applicant is Helix Medical, LLC. The 510(k) number is K082206.

When did BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES receive FDA 510(k) clearance?

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES received FDA 510(k) clearance on 2008-09-04, under 510(k) number K082206.

Who is the listed applicant for BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES?

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

What is the FDA product code for BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES?

The FDA product code for BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES is EWL.

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Other records listing Helix Medical, LLC 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.

K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISK131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISK093258BLOM-SINGER INDWELLING TEP OCCLUDER

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 ABK043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134Atos Medical AB

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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