PROVENT PROFESSIONAL SLEEP APNEA THERAPY
FDA 510(k) clearance K090398 · decided 2009-04-03
Clearance details
- K-number
- K090398
- Device name
- PROVENT PROFESSIONAL SLEEP APNEA THERAPY
- Applicant
- Ventus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-02-17
- Decision date
- 2009-04-03
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- OHP
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Belmont, CA, US
- Third-party review
- No
- Expedited review
- No
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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 NASAL DILATOR, MODEL BR2 (K071560) | Ventus Medical, Inc. | 2008-02-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; recall (Z-1033-2012) | Ventus Medical, Inc. | 2012-02-15 |