510(k) K240561
K240561 is an FDA 510(k) premarket notification submitted by Molecular Products , Ltd. for the device "Rugged Oxygen Generator (ROG) (RO01-00001)". The FDA issued a decision of Substantially Equivalent on December 6, 2024. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Molecular Products , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2024
- Date Received
- February 29, 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