510(k) K200496
K200496 is an FDA 510(k) premarket notification submitted by 3B Medical, Inc. for the device "Aer X". The FDA issued a decision of Substantially Equivalent on July 24, 2020. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. 3B Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2020
- Date Received
- February 28, 2020
- Clearance Type
- Special
- 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