510(k) K191417
K191417 is an FDA 510(k) premarket notification submitted by Belun Technology Company Limited for the device "Belun Ring". The FDA issued a decision of Substantially Equivalent on October 10, 2019. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Belun Technology Company Limited has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2019
- Date Received
- May 28, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type