510(k) K231620
K231620 is an FDA 510(k) premarket notification submitted by Smart Solutions Technologies SL for the device "Nuubo Smart". The FDA issued a decision of Substantially Equivalent on Aug 1, 2023. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Smart Solutions Technologies SL has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 2023
- Date Received
- Jun 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)