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FDA 510(k)

OSSTELL RESONANCE FREQUENCY ANALYZER

K-Number: K003714 · 2001-08-09

ApplicantIntegration Diagnostics, Ltd.
Decision Date2001-08-09
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSTELL RESONANCE FREQUENCY ANALYZER 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 2001-08-09 under 510(k) number K003714. 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 RESONANCE FREQUENCY ANALYZER?

OSSTELL RESONANCE FREQUENCY ANALYZER is a medical device that received FDA 510(k) clearance on 2001-08-09. The listed applicant is Integration Diagnostics, Ltd.. The 510(k) number is K003714.

When did OSSTELL RESONANCE FREQUENCY ANALYZER receive FDA 510(k) clearance?

OSSTELL RESONANCE FREQUENCY ANALYZER received FDA 510(k) clearance on 2001-08-09, under 510(k) number K003714.

Who is the listed applicant for OSSTELL RESONANCE FREQUENCY ANALYZER?

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 RESONANCE FREQUENCY ANALYZER?

The FDA product code for OSSTELL RESONANCE FREQUENCY ANALYZER is EKX.

Related Clinical Trials

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.

K033689OSSTELL MENTOR RFA

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

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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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