FDA 510K (K120446) FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
FDA 510K (K120446) FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
| Device Classification Name | Gastroscope And Accessories, Flexible/Rigid | |
|---|---|---|
| 510(k) Number | K120446 | |
| Device Name | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 | |
| Applicant Contact | MARK JOB | |
| Regulation Number | 876.1500 | |
| Classification Product Code |
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| Subsequent Product Code |
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| Date Received | 02/14/2012 | |
| Decision Date | 08/13/2012 | |
| Decision | Substantially Equivalent (SESE) | |
| Regulation Medical Specialty | Gastroenterology/Urology | |
| 510k Review Panel | Radiology | |
| Summary | Summary | |
| Type | Traditional | |
| Reviewed by Third Party | Yes | |
| Combination Product | No | |
| Predetermined Change Control Plan Authorized |
No | |
| Recalls | CDRH Recalls |
Total pages: 1621
Fully redacted pages: 824
Content pages: 797
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