Device Classification Name |
thermometer, electronic, clinical |
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---|---|---|---|---|
510(k) Number | K110956 | |||
Device Name | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR | |||
Applicant |
|
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Applicant Contact | lynne aronson | |||
Correspondent |
|
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Correspodent Contact | lynne aronson | |||
Regulation Number | 880.2910 | |||
Classification Product Code |
|
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Date Received | 04/05/2011 | |||
Decision Date | 07/18/2011 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
Gastroenterology/Urology |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |