510(k) K041773
K041773 is an FDA 510(k) premarket notification submitted by City Technology Limited for the device "OXYGEN MEDICELS, CITICELS". The FDA issued a decision of Substantially Equivalent on July 15, 2004. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2004
- Date Received
- July 1, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1720
- Review Panel
- AN
- Submission Type