510(k) K202851
K202851 is an FDA 510(k) premarket notification submitted by Jkh USA, LLC for the device "Spo2 Sensor". The FDA issued a decision of Substantially Equivalent on November 27, 2020. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Jkh USA, LLC has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2020
- Date Received
- September 28, 2020
- 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