Humidifier, Respiratory, Mask (Direct Patient Interface)
OBN is the FDA product code for Humidifier, Respiratory, Mask (Direct Patient Interface), a class II device type, regulated under 21 CFR 868.5450. FDA's definition for this code reads: "Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OBN
- Device name
- Humidifier, Respiratory, Mask (Direct Patient Interface)
- FDA definition
- Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.
- Regulation
- 21 CFR 868.5450
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OBN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
Applicants with the most clearances
Product code OBN| Applicant | Clearances |
|---|---|
| Polar Wrap, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OBN.
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