Drager ORMC

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K800764 ↗

FDA Product Code

BZR

Device Class

Class II

Regulation

21 CFR Part 868.5330

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K972848 Active Cleared 30 Oct 1997

• Spectramed Respiratory Gas Analyzer

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  FDA 510(k) K873194 Active Cleared 30 Oct 1987

• Evite Xl

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  FDA 510(k) K083050 Active Cleared 29 Dec 2008

• Vapor 19

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  FDA 510(k) K771899 Active Cleared 18 Oct 1977

• Nbp Cuff

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• Narkomed 6000 Model Number NM6000

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  FDA 510(k) K980553 Active Cleared 4 Aug 1998

See all devices from Draeger Medical, Inc. →

• What is the Drager ORMC used for?

  The Drager ORMC is a mixer specifically designed for breathing gases used in anesthesia inhalation. It is classified as a Class II medical device intended for anesthesiology applications in medical settings.

• Is the Drager ORMC a single-use device or reusable?

  The device data does not specify whether the Drager ORMC is designed for single-use or multiple reuse. This information would need to be obtained from the manufacturer's instructions for use or product documentation.

• What regulatory approvals does the Drager ORMC have?

  The Drager ORMC received FDA 510(k) clearance on April 29, 1980, with K number K800764. It is classified as a Class II medical device under product code BZR for anesthesiology applications.

• What are the storage requirements for the Drager ORMC?

  The provided device data does not include specific storage conditions for the Drager ORMC. Storage requirements would typically be detailed in the manufacturer's instructions for use or product documentation.