510(k) K071560
- Device
- PROVENT NASAL DILATOR, MODEL BR2
- Applicant
- VENTUS MEDICAL, INC.
- 510(k) number
- K071560
- Product code
- OHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-08
- Date received
- 2007-06-07
- Regulation
- 872.5570
- Classification name
- Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CINDY DOMECUS
- Address
- 1171 Barroilhet Dr. Hillsborough CA US 94010 94010
FDA Registration Numbers#
- 3016609920
- 3015239144
- 3014941496
Source Documents#
Other 510(k) Records For Product Code OHP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | 2020-02-21 |
| K180619 | Bongo | Innomed Healthscience, Inc. | 2018-08-16 |
| K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | Ventus Medical, Inc. | 2010-12-02 |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | Ventus Medical, Inc. | 2009-04-03 |
Legacy Summary#
summary
FDA Review#
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