510(k) K191420
K191420 is an FDA 510(k) premarket notification submitted by Shenzhen Changke Connect Electronics Co., Ltd. for the device "Reusable SpO2 Sensor". The FDA issued a decision of Substantially Equivalent on Oct 11, 2019. 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
- Oct 11, 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
- 510(k)