MAGTARAK Respiratory Monitor & Flow Sens
FDA 510(k)Class II (US FDA 510(k))
by Penlon, Inc.
Identifiers
- 510(k) Number
- K823555 FDA 510(k)
- FDA Product Code
- BZK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1850 FDA 510(k)
- Regulation Number
- 868.1850 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MAGTARAK Respiratory Monitor & Flow Sens is a device classified as a Spirometer, Monitoring (W/Wo Alarm), used in the field of Anesthesiology. It is designed to monitor respiratory functions and measure airflow in patients.
This device is authorized under FDA 510K clearance with product code BZK and is classified as Class II medical device. It is manufactured by Penlon, Inc. and is supplied in various sizes as indicated by the multiple registration numbers associated with the device.
Frequently asked questions
What is the MAGTARAK Respiratory Monitor & Flow Sens used for?
The MAGTARAK Respiratory Monitor & Flow Sens is a spirometer designed to monitor respiratory functions and measure airflow in patients, specifically in the field of anesthesiology.
What is the regulatory status of the MAGTARAK Respiratory Monitor & Flow Sens?
This device is authorized under FDA 510K clearance with product code BZK and is classified as a Class II medical device. It has been substantially equivalent to other devices in its classification.
How is the MAGTARAK Respiratory Monitor & Flow Sens supplied?
The device is supplied in various sizes as indicated by the multiple registration numbers associated with it. It is manufactured by Penlon, Inc. and is designed for use in clinical settings requiring respiratory monitoring.
What are the specifications of the MAGTARAK Respiratory Monitor & Flow Sens?
The MAGTARAK Respiratory Monitor & Flow Sens is classified as a Spirometer, Monitoring (W/Wo Alarm) and is intended for use in anesthesiology. It has received traditional clearance with decision code SESE, indicating it is substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K823555 | Class II | Active |
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Manufacturer
- Manufacturer
- Penlon, Inc.
Sources (1)
- FDA 510(k) K823555 24 fields · synced Oct 6, 2026