510(k) K190022
K190022 is an FDA 510(k) premarket notification submitted by MD Diagnostics Limited for the device "SafeBreath Filter Mouthpiece". The FDA issued a decision of Substantially Equivalent on September 25, 2019. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. MD Diagnostics Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2019
- Date Received
- January 4, 2019
- 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