510(k) K221979
K221979 is an FDA 510(k) premarket notification submitted by Shenzhen Imdk Medical Technology Co., Ltd. for the device "Pulse Oximeter (Model C101A2, C101B1, C101A3)". The FDA issued a decision of Substantially Equivalent on October 16, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Imdk Medical Technology Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2022
- Date Received
- July 5, 2022
- Clearance Type
- Special
- 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