510(k) K192177
K192177 is an FDA 510(k) premarket notification submitted by Sysmed (China) Co., Ltd. for the device "SysMed S/T". The FDA issued a decision of Substantially Equivalent on Nov 25, 2020. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Sysmed (China) Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 25, 2020
- Date Received
- Aug 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type
- 510(k)