OBN · Humidifier, Respiratory, Mask (Direct Patient Interface)
Anesthesiology · 21 CFR 868.5450 · Class 2
Overview
| Product Code | OBN |
|---|---|
| Device Name | Humidifier, Respiratory, Mask (Direct Patient Interface) |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070467 | HEALTH MASK | Polar Wrap, LLC | Apr 17, 2007 | SESE |
Top Applicants
- Polar Wrap, LLC — 1 clearance
