Identifiers
- 510(k) Number
- K891486 FDA 510(k)
- FDA Product Code
- BZQ 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 AR-800PA Respiration Module is a Monitor, Breathing Frequency device classified under product code BZQ and medical specialty Anesthesiology. It is designed to monitor breathing frequency as part of respiratory function assessment.
The device is supplied as a reusable module intended for use in clinical settings under the supervision of healthcare professionals. It received FDA 510(k) clearance (K891486) on October 24, 1989, and is classified as a Class II device subject to special controls under regulation number 868.2375.
Frequently asked questions
What is the AR-800PA Respiration Module used for?
The AR-800PA Respiration Module is designed to monitor breathing frequency as part of respiratory function assessment. It measures respiratory rate to support clinical evaluation of a patient’s ventilatory status during anesthesia or critical care monitoring.
Is the AR-800PA Respiration Module reusable or single-use?
The AR-800PA Respiration Module is supplied as a reusable device intended for repeated use in clinical settings. It is designed to be cleaned and maintained according to manufacturer guidelines for safe reuse under professional supervision.
How is the AR-800PA Respiration Module supplied and what regulatory pathway was used?
The device is supplied as a standalone monitoring module for integration with compatible patient monitors. It received FDA 510(k) clearance under K891486 on October 24, 1989, as a Class II device subject to special controls under regulation 868.2375.
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: K891486 FDA 510 (k) - AR-800PA RESPIRATION MODULE, AR-800PA RESPIRATION MODULE 510(k) K891486 - FDA.report, PDF K891486 - Ar-800pa Respiration Module, Nihon Kohden… — 166 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K891486 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K891486 24 fields · synced Sep 27, 2026