| Device Classification Name |
thermometer, electronic, clinical |
|||
|---|---|---|---|---|
| 510(k) Number | K991914 | |||
| Device Name | SUPER SOOTHER | |||
| Applicant |
|
|||
| Applicant Contact | jimmy dong | |||
| Correspondent |
|
|||
| Correspodent Contact | jimmy dong | |||
| Regulation Number | 880.2910 | |||
| Classification Product Code |
|
|||
| Date Received | 06/07/1999 | |||
| Decision Date | 10/06/1999 | |||
| 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 |