510(k) K221250
K221250 is an FDA 510(k) premarket notification submitted by Ndd Medizintechnik AG for the device "EasyOne Filter". The FDA issued a decision of Substantially Equivalent on November 22, 2022. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Ndd Medizintechnik AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2022
- Date Received
- May 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Bacterial, Breathing-Circuit
- Device Class
- Class II
- Regulation Number
- 868.5260
- Review Panel
- HO
- Submission Type