Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K851889 |
Device Name |
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY |
Applicant |
CLINICAL DATA, INC. |
1172 COMMONWEALTH AVE. |
BOSTON,
MA
02134
|
|
Applicant Contact |
ISRAEL M STEIN |
Correspondent |
CLINICAL DATA, INC. |
1172 COMMONWEALTH AVE. |
BOSTON,
MA
02134
|
|
Correspondent Contact |
ISRAEL M STEIN |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 04/30/1985 |
Decision Date | 10/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|