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FDA 510(k)

PROVOX 2 VOICE PROSTHESIS SYSTEM

K-Number: K971244 · 1997-06-06

ApplicantAtos Medical AB
Decision Date1997-06-06
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PROVOX 2 VOICE PROSTHESIS SYSTEM 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 1997-06-06 under 510(k) number K971244. 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 2 VOICE PROSTHESIS SYSTEM?

PROVOX 2 VOICE PROSTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Atos Medical AB. The 510(k) number is K971244.

When did PROVOX 2 VOICE PROSTHESIS SYSTEM receive FDA 510(k) clearance?

PROVOX 2 VOICE PROSTHESIS SYSTEM received FDA 510(k) clearance on 1997-06-06, under 510(k) number K971244.

Who is the listed applicant for PROVOX 2 VOICE PROSTHESIS SYSTEM?

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 2 VOICE PROSTHESIS SYSTEM?

The FDA product code for PROVOX 2 VOICE PROSTHESIS SYSTEM 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 HMEK043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

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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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