Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K984579 |
Device Name |
CAPNO PROBE A |
Applicant |
OPTICAL SENSORS, INC. |
7615 GOLDEN TRIANGLE DR., |
SUITE A |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
Gary J Syring |
Correspondent |
OPTICAL SENSORS, INC. |
7615 GOLDEN TRIANGLE DR., |
SUITE A |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
Gary J Syring |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/1998 |
Decision Date | 12/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|