Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K870858 |
Device Name |
BADGWELL SAMPLING CATHETER |
Applicant |
DRYDEN CORP. |
10640 EAST 59TH ST. |
P.O. BOX 36038 |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
DRYDEN CORP. |
10640 EAST 59TH ST. |
P.O. BOX 36038 |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 03/03/1987 |
Decision Date | 05/14/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|