510(k) K222794
K222794 is an FDA 510(k) premarket notification submitted by Baldus Sedation GmbH & Co. KG for the device "FlowStar Touch Digital Mixer Flowmeter". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Baldus Sedation GmbH & Co. KG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2023
- Date Received
- September 16, 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