510(k) K221494
K221494 is an FDA 510(k) premarket notification submitted by Dehas Medical Systems GmbH for the device "Quality Mix Blender, Oxymixer". The FDA issued a decision of Substantially Equivalent on January 23, 2023. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Dehas Medical Systems GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2023
- Date Received
- May 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Device Class
- Class II
- Regulation Number
- 868.5330
- Review Panel
- AN
- Submission Type