Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K160636 |
Device Name |
iPEP System and vPEP |
Applicant |
D R BURTON HEALTHCARE LLC |
3936 S FIELDS ST |
FARMVILLE,
NC
27828
|
|
Applicant Contact |
DENNIS COOK |
Correspondent |
D R BURTON HEALTHCARE LLC |
3936 S FIELDS ST |
FARMVILLE,
NC
27828
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 03/07/2016 |
Decision Date | 08/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|