| Device Classification Name |
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
|
| 510(k) Number |
K853360 |
| Device Name |
N20 TEST |
| Applicant |
| Erich Jaeger, Inc. |
| 5251 Zenith Pkwy. |
|
Rockford,
IL
61111
|
|
| Applicant Contact |
RONALD EVENSON |
| Correspondent |
| Erich Jaeger, Inc. |
| 5251 Zenith Pkwy. |
|
Rockford,
IL
61111
|
|
| Correspondent Contact |
RONALD EVENSON |
| Regulation Number | 868.1700 |
| Classification Product Code |
|
| Date Received | 08/12/1985 |
| Decision Date | 09/03/1985 |
| 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
|
|
|