CM7000 Remote Indicator

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

510(k) Number

K931287 ↗

FDA Product Code

CAP

FDA applicant

Canadian Monaghan , Ltd.

Device Class

Class II

Regulation

21 CFR Part 868.2600

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• CM 5000 Monitor Airway Pressure

  Class II

  FDA 510(k) K871083 Active Cleared 8 Apr 1987

• Cm 5000R Remote Airway Pressure

  Class II

  FDA 510(k) K873953 Active Cleared 27 Oct 1987

• CM5000R Remote Indicator

  Class II

  FDA 510(k) K931394 Active Cleared 1 Jul 1993

• Airway Pressure Monitor Cm 5000 Ngan

  Class II

  FDA 510(k) K925673 Active Cleared 9 Jun 1993

• What is the CM7000 Remote Indicator used for?

  The CM7000 Remote Indicator is a monitor for airway pressure that includes a gauge and/or alarm. It is designed to provide real-time monitoring of airway pressure during medical procedures in anesthesiology settings.

• Is the CM7000 Remote Indicator a single-use or reusable device?

  The CM7000 Remote Indicator is supplied as a reusable medical device. It is not specified as MRI safe and is intended for repeated use in clinical environments where airway pressure monitoring is required.

• What is the regulatory status of the CM7000 Remote Indicator?

  The CM7000 Remote Indicator is authorized under FDA 510K clearance with product code CAP. It has been cleared for monitoring airway pressure in clinical environments and is manufactured by Canadian Monaghan, Ltd.

• In what settings is the CM7000 Remote Indicator typically used?

  The CM7000 Remote Indicator is intended for use in anesthesiology settings where real-time monitoring of airway pressure is necessary during medical procedures. It is designed to provide accurate pressure readings with visual gauge and/or alarm indicators.