FLUOROspeed
System, X-ray, Fluoroscopic, Image-intensified
Shimadzu Corporation
The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Fluorospeed.
Pre-market Notification Details
| Device ID | K191877 |
| 510k Number | K191877 |
| Device Name: | FLUOROspeed |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Shimadzu Corporation 1 Nishinokyo-Kuwabaracho Nakagyo-ku Kyoto, JP 604-8511 |
| Contact | Toshio Kadowaki |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2019-08-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04540217061716 | K191877 | 000 |
| 04540217061723 | K191877 | 000 |
| 04540217065271 | K191877 | 000 |
Trademark Results [FLUOROspeed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLUOROSPEED 88708585 not registered Live/Pending |
Shimadzu Corporation 2019-11-27 |
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