Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K130663 |
Device Name |
BESTFIT2 NASAL MASK |
Applicant |
CURATIVE MEDICAL INC. |
6518 TAMARIND SKY LN. |
FULSHEAR,
TX
77441
|
|
Applicant Contact |
AMY MCKINNEY |
Correspondent |
CURATIVE MEDICAL INC. |
6518 TAMARIND SKY LN. |
FULSHEAR,
TX
77441
|
|
Correspondent Contact |
AMY MCKINNEY |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/12/2013 |
Decision Date | 09/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|