| Device Classification Name |
Apparatus, Gas-Scavenging
|
| 510(k) Number |
K945216 |
| Device Name |
AES, (ANESCO EVACUATION SYSTEM) ACTIVE WASTE ANESTHETIC GAS EVACUATION SYSTEM |
| Applicant |
| ANESCO |
| 115 ETTER LN. |
|
GEORGETOWN,
KY
40324
|
|
| Applicant Contact |
JOHN ENGLE |
| Correspondent |
| ANESCO |
| 115 ETTER LN. |
|
GEORGETOWN,
KY
40324
|
|
| Correspondent Contact |
JOHN ENGLE |
| Regulation Number | 868.5430 |
| Classification Product Code |
|
| Date Received | 10/25/1994 |
| Decision Date | 09/15/1995 |
| 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
|
|
|