510(k) K233418
K233418 is an FDA 510(k) premarket notification submitted by Biofourmis Singapore Pte., Ltd. for the device "Biofourmis Everion+ (G2)". The FDA issued a decision of Substantially Equivalent on May 9, 2024. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Biofourmis Singapore Pte., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2024
- Date Received
- October 10, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type