510(k) K200069
K200069 is an FDA 510(k) premarket notification submitted by Shenzhen Changke Connect Electronics Co., Ltd. for the device "Disposable SpO2 Sensor". The FDA issued a decision of Substantially Equivalent on Mar 13, 2020. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Changke Connect Electronics Co., Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 2020
- Date Received
- Jan 13, 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
- 510(k)