| Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
| 510(k) Number |
K884090 |
| Device Name |
LUNDY VAPORIZER SYSTEM |
| Applicant |
| Vaporflow Technology, Inc. |
| 1731 Saybrook Ln. |
|
Tustin,
CA
92680
|
|
| Applicant Contact |
JOHN C LUNDY |
| Correspondent |
| Vaporflow Technology, Inc. |
| 1731 Saybrook Ln. |
|
Tustin,
CA
92680
|
|
| Correspondent Contact |
JOHN C LUNDY |
| Regulation Number | 868.5880 |
| Classification Product Code |
|
| Date Received | 09/28/1988 |
| Decision Date | 01/24/1989 |
| 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
|
|
|