Device Classification Name |
monitor, airway pressure (includes gauge and/or alarm)
|
510(k) Number |
K050309 |
Device Name |
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 |
Applicant |
VIASYS MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
STEPHANIE WASIELEWSKI |
Correspondent |
VIASYS MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
STEPHANIE WASIELEWSKI |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 02/08/2005 |
Decision Date | 03/25/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|