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FDA 510(k)

OSSTELL MENTOR RFA

K-Number: K033689 · 2004-02-26

ApplicantIntegration Diagnostics, Ltd.
Decision Date2004-02-26
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSTELL MENTOR RFA is the device name listed in this FDA 510(k) record. The listed applicant is Integration Diagnostics, Ltd.. It received FDA 510(k) clearance on 2004-02-26 under 510(k) number K033689. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSTELL MENTOR RFA?

OSSTELL MENTOR RFA is a medical device that received FDA 510(k) clearance on 2004-02-26. The listed applicant is Integration Diagnostics, Ltd.. The 510(k) number is K033689.

When did OSSTELL MENTOR RFA receive FDA 510(k) clearance?

OSSTELL MENTOR RFA received FDA 510(k) clearance on 2004-02-26, under 510(k) number K033689.

Who is the listed applicant for OSSTELL MENTOR RFA?

The FDA 510(k) record lists Integration Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSTELL MENTOR RFA?

The FDA product code for OSSTELL MENTOR RFA is EKX.

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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.

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Other records listing Integration Diagnostics, Ltd. 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.

K003714OSSTELL RESONANCE FREQUENCY ANALYZER

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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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