Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K851658 |
Device Name |
CAPNOMED |
Applicant |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
EDWARD T GRIFFITH |
Correspondent |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
EDWARD T GRIFFITH |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 04/23/1985 |
Decision Date | 05/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|