| Device Classification Name |
thermometer, electronic, clinical
|
|---|
| 510(k) Number |
K100563 |
|---|
| Device Name |
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA |
|---|
| Applicant |
| GEON CORPORATION |
| 2904 N. BOLDT DRIVE |
|
FLAGSTAFF,
AZ
86001
|
|
| Applicant Contact |
JENNIFER REICH |
| Correspondent |
| GEON CORPORATION |
| 2904 N. BOLDT DRIVE |
|
FLAGSTAFF,
AZ
86001
|
|
| Correspondent Contact |
JENNIFER REICH |
| Regulation Number | 880.2910
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/01/2010 |
|---|
| Decision Date | 06/02/2010 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General Hospital
|
|---|
| 510k Review Panel |
General Hospital
|
|---|
| Statement |
Statement
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|