510(k) K253166
K253166 is an FDA 510(k) premarket notification submitted by BMC Medical Co., Ltd. for the device "F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)". The FDA issued a decision of Substantially Equivalent on April 29, 2026. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. BMC Medical Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2026
- Date Received
- September 26, 2025
- 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