Identifiers
- 510(k) Number
- K894691 FDA 510(k)
- FDA Product Code
- CCK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1400 FDA 510(k)
- Regulation Number
- 868.1400 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model AO-800PA CO2 Module is an analyzer for gaseous-phase carbon dioxide, classified under product code CCK as a carbon dioxide gas analyzer. It is a medical device designed to measure carbon dioxide levels in gaseous samples.
The device was submitted by Nihon Kohden America, Inc. and received FDA 510(k) clearance (K894691) on December 22, 1989, following a traditional review process. It is classified as a Class II device with special controls and falls under the anesthesiology advisory committee category.
Frequently asked questions
What is the Model AO-800PA CO2 Module used for?
The Model AO-800PA CO2 Module is a medical device designed to measure carbon dioxide levels in gaseous samples. It is classified as a carbon dioxide gas analyzer under product code CCK.
What is the regulatory status of the AO-800PA CO2 Module?
The device received FDA 510(k) clearance (K894691) on December 22, 1989, following a traditional review process. It is classified as a Class II device with special controls under the anesthesiology advisory committee category.
Is the AO-800PA CO2 Module reusable or single-use?
The device data does not specify whether the AO-800PA CO2 Module is reusable or single-use. For information regarding reuse or disposal, please consult the manufacturer's instructions or contact Nihon Kohden America, Inc. directly.
What sizes or models of the CO2 Module are available?
The device data specifically mentions the Model AO-800PA CO2 Module. No other sizes or models are referenced in the provided information.
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: MODEL AO-800PA CO2 MODULE (K894691) - FDA 510 (k), MODEL AO-800PA CO2 MODULE (K894691) — FDA 510(k) | Innolitics, MODEL AO-800PA CO2 MODULE 510(k) K894691 - FDA.report, fda.innolitics.com, 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 | K894691 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K894691 24 fields · synced Sep 26, 2026