510(k) K221267
K221267 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. for the device "VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor". The FDA issued a decision of Substantially Equivalent on Dec 15, 2022. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2022
- Date Received
- May 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)