510(k) K022684
K022684 is an FDA 510(k) premarket notification submitted by Essex Cryogenics of Missouri, Inc. for the device "PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)". The FDA issued a decision of Substantially Equivalent on September 11, 2002. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Essex Cryogenics of Missouri, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2002
- Date Received
- August 12, 2002
- Clearance Type
- Abbreviated
- 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