Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K121999 |
Device Name |
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE |
Applicant |
DRAEGER MEDICAL GMBH |
6 TECH DR |
ANDOVER,
MA
01810
|
|
Applicant Contact |
BETH ZIS |
Correspondent |
DRAEGER MEDICAL GMBH |
6 TECH DR |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
BETH ZIS |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 07/09/2012 |
Decision Date | 02/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|