Informed Remote Field Unit Model IFM1000

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K821712 ↗

FDA Product Code

BTY

Device Class

Class II

Regulation

21 CFR Part 868.1890

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Burditt & Calkins-Siemens-Elema →

• What is the primary function of the Informed Remote Field Unit Model IFM1000?

  This device functions as a calculator for predicted values of pulmonary function. It is specifically designed to assist clinicians in the assessment of various respiratory parameters.

• What is the regulatory status of this device?

  The Informed Remote Field Unit Model IFM1000 is identified under FDA 510(k) clearance K821712. It is classified under regulation number 868.1890 within the anesthesiology medical specialty.

• How is this device classified within the medical specialty?

  The device is classified as a calculator for predicted pulmonary function values under regulation number 868.1890. It falls under the anesthesiology medical specialty and is categorized as a class 2 device.