Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K051873 |
Device Name |
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES |
Applicant |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL C KENT |
Correspondent |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL C KENT |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 07/11/2005 |
Decision Date | 09/20/2005 |
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
|
Recalls |
CDRH Recalls
|
|
|