510(k) K240375
K240375 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "V80 Anesthetic Vaporizer (V80)". The FDA issued a decision of Substantially Equivalent on October 31, 2024. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. 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
- October 31, 2024
- Date Received
- February 7, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vaporizer, Anesthesia, Non-Heated
- Device Class
- Class II
- Regulation Number
- 868.5880
- Review Panel
- AN
- Submission Type