Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K121696 |
Device Name |
WIRELESS THERMOMETER |
Applicant |
RALING MEDICAL COMPANY |
NO. 11, HUATONG RD |
BEIJING,
CN
102200
|
|
Applicant Contact |
WU WEI |
Correspondent |
RALING MEDICAL COMPANY |
NO. 11, HUATONG RD |
BEIJING,
CN
102200
|
|
Correspondent Contact |
WU WEI |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 06/07/2012 |
Decision Date | 10/11/2012 |
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
|
|
|