Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K912650 |
Device Name |
1.1, 1.2, 1.3 TEMPERATURE PROBES |
Applicant |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Applicant Contact |
ALBERTO VELEZ |
Correspondent |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Correspondent Contact |
ALBERTO VELEZ |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 06/17/1991 |
Decision Date | 08/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|