FADASSI MEDICAL FM-1 NO BLENDER
Device Facts
| Record ID | K003665 |
|---|---|
| Device Name | FADASSI MEDICAL FM-1 NO BLENDER |
| Applicant | Fadasis Medical, Inc. |
| Product Code | MRO · Anesthesiology |
| Decision Date | Feb 23, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5165 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
Special Controls
The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
The special control developed by the agency is a guidance document, entitled Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer. This guidance document identifies the risks associated with these types of devices and contains information that will help manufacturers address those risks. This document is available on FDA's website at http://www.fda.gov/cdrh/ode/1157.pdf.
