Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K050837 |
Device Name |
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE |
Applicant |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 04/01/2005 |
Decision Date | 04/27/2005 |
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
|
|
|