Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K895780 |
Device Name |
OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER |
Applicant |
DATEX DIVISION INSTRUMENTARIUM CORP. |
P.O. BOX 446 |
SF-00101 |
HELSINKI, FINLAND,
FI
|
|
Applicant Contact |
HANNU AHJOPALO |
Correspondent |
DATEX DIVISION INSTRUMENTARIUM CORP. |
P.O. BOX 446 |
SF-00101 |
HELSINKI, FINLAND,
FI
|
|
Correspondent Contact |
HANNU AHJOPALO |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 09/27/1989 |
Decision Date | 11/29/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|