Device Classification Name |
expiratory resistance valve, intranasal, for obstructive sleep apnea
|
510(k) Number |
K102404 |
Device Name |
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) |
Applicant |
VENTUS MEDICAL, INC. |
1301 SHOREWAY ROAD |
SUITE 425 |
belmont,
CA
94002
|
|
Applicant Contact |
michael nevares |
Correspondent |
VENTUS MEDICAL, INC. |
1301 SHOREWAY ROAD |
SUITE 425 |
belmont,
CA
94002
|
|
Correspondent Contact |
michael nevares |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 08/24/2010 |
Decision Date | 12/02/2010 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|