510(k) K243049
K243049 is an FDA 510(k) premarket notification submitted by Hunan Accurate Bio-Medical Technology Co., Ltd. for the device "Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)". The FDA issued a decision of Substantially Equivalent on January 2, 2025. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Hunan Accurate Bio-Medical Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 2025
- Date Received
- September 27, 2024
- 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