510(k) K212752
K212752 is an FDA 510(k) premarket notification submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. for the device "Med-link Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on May 20, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Med-Link Electronics Tech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2022
- Date Received
- August 30, 2021
- 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