510(k) K200637
K200637 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) for the device "SR-8100 Portable X-ray Unit". The FDA issued a decision of Substantially Equivalent on Jul 9, 2020. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Shantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 9, 2020
- Date Received
- Mar 10, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)