510(k) K213169
K213169 is an FDA 510(k) premarket notification submitted by BMC Medical Co., Ltd. for the device "BPAP System". The FDA issued a decision of Substantially Equivalent on December 5, 2022. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. BMC Medical Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2022
- Date Received
- September 28, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Non-Life-Supporting
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type