Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K061099 |
Device Name |
BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 |
Applicant |
HOFFMAN LABORATORIES, LLC |
9305 ETON AVENUE |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
KEITH BOSECKER |
Correspondent |
HOFFMAN LABORATORIES, LLC |
9305 ETON AVENUE |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
KEITH BOSECKER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 04/19/2006 |
Decision Date | 08/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|