510(k) K170607
K170607 is an FDA 510(k) premarket notification submitted by Solutions For Tomorrow AB for the device "!M1". The FDA issued a decision of Substantially Equivalent on July 17, 2017. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Solutions For Tomorrow AB has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2017
- Date Received
- March 1, 2017
- 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