Device Classification Name |
monitor, bed patient
|
510(k) Number |
K873806 |
Device Name |
JDM SP2 SENSOR |
Applicant |
JD MONITORING C/O MACKLER, COOPER AND GIBBS |
SUITE 615 |
1220 L STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
JEFFREY N GIBBS |
Correspondent |
JD MONITORING C/O MACKLER, COOPER AND GIBBS |
SUITE 615 |
1220 L STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
JEFFREY N GIBBS |
Regulation Number | 880.2400
|
Classification Product Code |
|
Date Received | 09/18/1987 |
Decision Date | 12/08/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|