| Device Classification Name |
coil, magnetic resonance, specialty |
|||
|---|---|---|---|---|
| 510(k) Number | K010140 | |||
| Device Name | HRH-127 HEAD ARRAY COIL | |||
| Original Applicant |
|
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| Original Contact | thomas schubert | |||
| Regulation Number | 892.1000 | |||
| Classification Product Code |
|
|||
| Date Received | 01/17/2001 | |||
| Decision Date | 02/22/2001 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Radiology |
|||
| 510k Review Panel |
Radiology |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |