CM 5000 Monitor Airway Pressure
510(k) K871083
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871083 | Date8 Apr 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- 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
Overview
AI-generated summary, 27 Sep 2026
The CM 5000 Monitor Airway Pressure is a medical device designed to monitor airway pressure. It includes a gauge and an alarm system to assist in clinical settings.
This device is manufactured by Canadian Monaghan, Ltd. and has received FDA 510(k) clearance. It is classified under regulation number 868.2600 for use in anesthesiology.
Other devices from Canadian Monaghan, Ltd.
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the CM 5000 Monitor Airway Pressure?
This device is designed to monitor airway pressure in clinical settings. It incorporates a gauge and an alarm system to provide clinicians with necessary pressure data and alerts.
What is the regulatory status of this device?
The CM 5000 Monitor Airway Pressure has received FDA 510(k) clearance. It is classified under regulation number 868.2600 for use within the field of anesthesiology.
Which medical specialty is this monitor intended for?
The device is intended for use in anesthesiology. This classification is based on its regulatory designation under the anesthesiology advisory committee.