PROVENT NASAL DILATOR, MODEL BR2
FDA 510(k) clearance K071560 · decided 2008-02-08
Clearance details
- K-number
- K071560
- Device name
- PROVENT NASAL DILATOR, MODEL BR2
- Applicant
- Ventus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-07
- Decision date
- 2008-02-08
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- OHP
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hillsborough, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ventus Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ULTepap Expiratory Positive Airway Pressure (EPAP) Device (K191728) | Bryggs Medical, LLC | 2020-02-21 |
| Bongo (K180619) | Innomed Healthscience, Inc. | 2018-08-16 |
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) (K102404) | Ventus Medical, Inc. | 2010-12-02 |
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (K090398) | Ventus Medical, Inc. | 2009-04-03 |
Recalls involving this device
No recalls on record reference this clearance.