federal_register: 00-1535
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-1535 | Medical Devices; Guidance Document for Premarket Notification Submissions for the Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance Document for Premarket Notification Submissions for the Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer." This guidance will serve as a special control for nitric oxide delivery apparatus; nitric oxide analyzer; and nitrogen dioxide analyzer. FDA's Center for Devices and Radiological Health (CDRH) believes that this guidance is necessary to provide reasonable assurance of the safety and effectiveness of these devices. The guidance document includes material specific for the devices, consensus standards for electrical safety, electromagnetic compatibility, software and hardware documentation, and resistance to environmental effects. | 2000-01-24 | 2000 | 1 | https://www.federalregister.gov/documents/2000/01/24/00-1535/medical-devices-guidance-document-for-premarket-notification-submissions-for-the-nitric-oxide | https://www.govinfo.gov/content/pkg/FR-2000-01-24/pdf/00-1535.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance Document for Premarket Notification Submissions for the Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide... |