| Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
| 510(k) Number |
K990098 |
| Device Name |
VENTLAB VERIFY II |
| Applicant |
| Ventlab Corp. |
| P.O. Box 4341 |
|
Crofton,
MD
21114 -4341
|
|
| Applicant Contact |
E J SMITH |
| Correspondent |
| Ventlab Corp. |
| P.O. Box 4341 |
|
Crofton,
MD
21114 -4341
|
|
| Correspondent Contact |
E J SMITH |
| Regulation Number | 868.5730 |
| Classification Product Code |
|
| Date Received | 01/12/1999 |
| Decision Date | 02/11/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|