Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K882377 |
Device Name |
HEALTH-WATCH BED MONITOR |
Applicant |
ENGINEERING DEVELOPMENTS, CO. |
47 WILLOW RD. |
TINTON FALLS,
NJ
07724
|
|
Applicant Contact |
CARL ORLANDO |
Correspondent |
ENGINEERING DEVELOPMENTS, CO. |
47 WILLOW RD. |
TINTON FALLS,
NJ
07724
|
|
Correspondent Contact |
CARL ORLANDO |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 06/08/1988 |
Decision Date | 11/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|