# Medical Devices; Anesthesiology Devices; Classification of Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer
> **Food and Drug Administration** · Final rule. · Published 2000-03-03 · Effective 2000-04-03 · 65 FR 11464
## Document
- **Document number:** 00-5160
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 11464
- **CFR reference:** 21 CFR 868
- **Publication date:** 2000-03-03
- **Effective date:** 2000-04-03
- **HHS docket:** Docket No. 96P-0436
## Abstract

The Food and Drug Administration (FDA) is classifying the nitric oxide administration apparatus, nitric oxide analyzer, and nitrogen dioxide analyzer into class II (special controls). The special control that will apply to these devices is a guidance document. The agency is taking this action in response to a petition submitted under the Federal, Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/03/03/00-5160/medical-devices-anesthesiology-devices-classification-of-nitric-oxide-administration-apparatus)
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