Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K960854 |
Device Name |
SIEMENS SERVO ULTRA NEBULIZER 345 |
Applicant |
PACESETTER, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -3577
|
|
Applicant Contact |
STEVEN CLARKE |
Correspondent |
PACESETTER, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -3577
|
|
Correspondent Contact |
STEVEN CLARKE |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/01/1996 |
Decision Date | 12/23/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|