510(k) K201360
K201360 is an FDA 510(k) premarket notification submitted by Xinkang Medical Instrument Co. , Ltd. for the device "Reusable and Disposable SpO2 Sensors". The FDA issued a decision of Substantially Equivalent on August 19, 2020. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Xinkang Medical Instrument Co. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2020
- Date Received
- May 21, 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