Device Classification Name |
system, nuclear magnetic resonance imaging |
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---|---|---|---|---|
510(k) Number | K991943 | |||
Device Name | MRGP OPTICAL TRACKING UNIT | |||
Applicant |
|
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Applicant Contact | elaine k keeler | |||
Correspondent |
|
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Correspodent Contact | elaine k keeler | |||
Regulation Number | 892.1000 | |||
Classification Product Code |
|
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Date Received | 06/09/1999 | |||
Decision Date | 08/23/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Radiology |
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510k Review Panel |
Radiology |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |