510(k) K033000
K033000 is an FDA 510(k) premarket notification submitted by Essex Cryogenics of Missouri, Inc. for the device "NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on March 22, 2004. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Essex Cryogenics of Missouri, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 2004
- Date Received
- September 25, 2003
- Clearance Type
- Traditional
- Expedited Review
- Yes
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Liquid-Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5655
- Review Panel
- AN
- Submission Type