510(k) K260171
K260171 is an FDA 510(k) premarket notification submitted by BMC Medical Co., Ltd. for the device "Portable Oxygen Concentrator (PO1 5B, PO1 6B)". The FDA issued a decision of Substantially Equivalent on August 14, 2026. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. BMC Medical Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2026
- Date Received
- January 21, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type