Device Classification Name |
Monitor, Carbon-Dioxide, Cutaneous
|
510(k) Number |
K041548 |
Device Name |
SENTEC DIGITAL MONITOR MODEL #SDM |
Applicant |
SENTEC INC. |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Applicant Contact |
STEPHEN GORSKI |
Correspondent |
SENTEC INC. |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Correspondent Contact |
STEPHEN GORSKI |
Regulation Number | 868.2480
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2004 |
Decision Date | 08/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|