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FDA Statement The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, you can bid on this item only if you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item. Seller name:dr.baistra City,State:SHENZHEN,China Telephone number:0755-32870423 |
Device Classification Name | System, X-Ray, Mobile |
510(K) Number | K200976 |
Device Name | SR-8230, SR-8230S Portable X-Ray Unit |
Regulation Number | 892.172 |
Classification Product Code | IZL |
Date Received | 4/13/2020 |
Decision Date | 6/10/2020 |
Decision | Substantially Equivalent (SESE) |
Regulation Medical Specialty | Radiology |
510k Review Panel | Radiology |
Summary | Summary |
Type | Traditional |
Reviewed By Third Party | No |
Combination Product | No |