| Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
| 510(k) Number |
K860556 |
| Device Name |
SERIES 7050 CAPNOGRAPH |
| Applicant |
| MARQUETTE ELECTRONICS, INC. |
| 8200 WEST TOWER AVE. |
|
MILWAUKEE,
WI
53223
|
|
| Applicant Contact |
THOMAS MASSOPUST |
| Correspondent |
| MARQUETTE ELECTRONICS, INC. |
| 8200 WEST TOWER AVE. |
|
MILWAUKEE,
WI
53223
|
|
| Correspondent Contact |
THOMAS MASSOPUST |
| Regulation Number | 868.1400 |
| Classification Product Code |
|
| Date Received | 02/14/1986 |
| Decision Date | 02/21/1986 |
| 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
|
|
|