Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K896934 |
Device Name |
KNIGHTWATCH SYSTEM |
Applicant |
CREATECH CORP. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
STEPHEN LAWRENCE |
Correspondent |
CREATECH CORP. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
STEPHEN LAWRENCE |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 12/13/1989 |
Decision Date | 06/25/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|