510(k) K121531
K121531 is an FDA 510(k) premarket notification submitted by Zhongshan A&J Medical Equipment Co., Ltd. for the device "A&J 5L POCA SERIES OXYGEN CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on July 17, 2012. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Zhongshan A&J Medical Equipment Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2012
- Date Received
- May 24, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type