510(k) K150167
K150167 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "V60 Anesthetic Vaporizer". The FDA issued a decision of Substantially Equivalent on June 30, 2015. 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
- June 30, 2015
- Date Received
- January 26, 2015
- 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