Pressure Transducer Airflow Sensor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K982293 FDA 510(k)
- FDA Product Code
- MNR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pressure Transducer Airflow Sensor is a medical device designed to detect respiratory airflow and generate accurate signals. It is used in sleep diagnostics and can produce flow-based snore channel data. The device is available in different configurations, including AC-only models like the PTAF Lite and models that can be used in both AC and DC configurations like the PTAF2.
This device is supplied by Pro-Tech Services, Inc. and is classified as a Class II medical device. It is authorized under FDA 510K clearance with product code MNR and is intended for use in anesthesiology applications. The device is not specified as single-use or reusable, and no information regarding MRI safety or storage conditions is provided in the data.
Frequently asked questions
What is the Pressure Transducer Airflow Sensor used for?
The Pressure Transducer Airflow Sensor is designed to detect respiratory airflow and generate accurate signals. It is used in sleep diagnostics and can produce flow-based snore channel data, making it useful for monitoring respiratory patterns during sleep studies.
What configurations are available for this device?
The device is available in different configurations, including AC-only models like the PTAF Lite and models that can be used in both AC and DC configurations like the PTAF2, providing flexibility for various clinical applications.
Is this device single-use or reusable?
The device is not specified as single-use or reusable in the provided information. Users should consult the manufacturer's instructions for specific guidance on the intended use and disposal of the device.
What is the regulatory classification of this device?
The Pressure Transducer Airflow Sensor is classified as a Class II medical device and is authorized under FDA 510K clearance with product code MNR. It is intended for use in anesthesiology applications and received special clearance in 1998.
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. Sources consulted: Pro-Tech PTAF lite Pressure Transducer - MVAP Med, PDF Pro-Tech diagnostic sensor catalog - images.philips.com, Pressure transducer airflow sensors | Gramercy Drugs & Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982293 | Class II | Active |
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Manufacturer
- Manufacturer
- Pro-Tech Services, Inc.
Sources (1)
- FDA 510(k) K982293 24 fields · synced Sep 22, 2026