Device Classification Name |
sleep appliances with patient monitoring
|
510(k) Number |
K181571 |
Device Name |
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor |
Applicant |
Mark Abramson, D.D.S., Inc |
35 Renato Court |
Redwood City,
CA
94061
|
|
Applicant Contact |
Mark Abramson |
Correspondent |
FisherMed Consulting LLC |
820 Civic Center Drive |
Santa Clara,
CA
95050
|
|
Correspondent Contact |
Cheryl Fisher |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 06/14/2018 |
Decision Date | 04/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|