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FDA 510(k)

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

K-Number: K043138 · 2004-11-22

ApplicantAtos Medical AB
Decision Date2004-11-22
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 is the device name listed in this FDA 510(k) record. The listed applicant is Atos Medical AB. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K043138. 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 PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134?

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Atos Medical AB. The 510(k) number is K043138.

When did PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 receive FDA 510(k) clearance?

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 received FDA 510(k) clearance on 2004-11-22, under 510(k) number K043138.

Who is the listed applicant for PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134?

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

What is the FDA product code for PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134?

The FDA product code for PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 is EWL.

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Other records listing Atos Medical AB 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.

K151404ProTrach DualcareK131947PROVOX VEGA PUNCTURE SETK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)K090455PROVOX VEGA, MODEL 8130-8135K072582PROVOX MICRON HMEK022125PROVOX FREEHANDS HME, MODEL 7710

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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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