510(k) K252182
K252182 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "SV70 Ventilator (SV70)". The FDA issued a decision of Substantially Equivalent on April 6, 2026. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2026
- Date Received
- July 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sv70 Ventilator
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type