| Device Classification Name |
Set, Tubing And Support, Ventilator (W Harness)
|
| 510(k) Number |
K890011 |
| Device Name |
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING |
| Applicant |
| Life Design Systems, Inc. |
| 5900 W. Franklin Dr. |
|
Franklin,
WI
53132
|
|
| Applicant Contact |
ALAN E WHITMARSH |
| Correspondent |
| Life Design Systems, Inc. |
| 5900 W. Franklin Dr. |
|
Franklin,
WI
53132
|
|
| Correspondent Contact |
ALAN E WHITMARSH |
| Regulation Number | 868.5975 |
| Classification Product Code |
|
| Date Received | 01/03/1989 |
| Decision Date | 03/20/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|