510(k) K243833
K243833 is an FDA 510(k) premarket notification submitted by Longfian Scitech Co., Ltd. for the device "Portable oxygen concentrator (JAY-1000P)". The FDA issued a decision of Substantially Equivalent on September 29, 2025. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Longfian Scitech Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2025
- Date Received
- December 13, 2024
- 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