510(k) K122290
K122290 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "ENVITEC MYSIGN O OXYGEN MEASURING DEVICE". The FDA issued a decision of Substantially Equivalent on January 23, 2013. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Envitec-Wismar GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2013
- Date Received
- July 30, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1720
- Review Panel
- AN
- Submission Type