Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K110629 |
Device Name |
RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER |
Applicant |
3B PRODUCTS, INC. |
9109 COPENHAVER DRIVE |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMA F ESTRIN, PH.D. |
Correspondent |
3B PRODUCTS, INC. |
9109 COPENHAVER DRIVE |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMA F ESTRIN, PH.D. |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/04/2011 |
Decision Date | 04/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|