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FDA 510(k)

PROVOX VEGA, MODEL 8130-8135

K-Number: K090455 · 2009-06-05

ApplicantAtos Medical AB
Decision Date2009-06-05
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PROVOX VEGA, MODEL 8130-8135 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 2009-06-05 under 510(k) number K090455. 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 VEGA, MODEL 8130-8135?

PROVOX VEGA, MODEL 8130-8135 is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Atos Medical AB. The 510(k) number is K090455.

When did PROVOX VEGA, MODEL 8130-8135 receive FDA 510(k) clearance?

PROVOX VEGA, MODEL 8130-8135 received FDA 510(k) clearance on 2009-06-05, under 510(k) number K090455.

Who is the listed applicant for PROVOX VEGA, MODEL 8130-8135?

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 VEGA, MODEL 8130-8135?

The FDA product code for PROVOX VEGA, MODEL 8130-8135 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)K072582PROVOX MICRON HMEK043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134K022125PROVOX 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, LLCK082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESHelix Medical, LLCK043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134Atos Medical AB

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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