Model Bion 2/Type 90 Room Ionizer

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K851358 ↗

FDA Product Code

FRF

FDA applicant

Medicor USA , Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5045

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K840225 Active Cleared 22 Mar 1984

• Medicor Quality Control Buffer

  Class I

  FDA 510(k) K791287 Active Cleared 16 Aug 1979

• Motor Tilted Exam. Table Uv-56

  Class II

  FDA 510(k) K840226 Active Cleared 16 Mar 1984

• Urolix-3 Urological Table

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  FDA 510(k) K840227 Active Cleared 23 Mar 1984

• Precision Gas Mixer

  Class I

  FDA 510(k) K781417 Active Cleared 20 Sep 1978

• Syringe Tonometer

  Not classified

  FDA 510(k) K790803 Active Cleared 28 Jun 1979

See all devices from Medicor USA, Ltd. →