510(k) K180871
K180871 is an FDA 510(k) premarket notification submitted by Microbase Technology Corporation for the device "Portable Nebulizer". The FDA issued a decision of Substantially Equivalent on Sep 14, 2018. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Microbase Technology Corporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 14, 2018
- Date Received
- Apr 3, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
- 510(k)