510(k) K182638
K182638 is an FDA 510(k) premarket notification submitted by Adherium (Nz), Ltd. for the device "Hailie Sensor". The FDA issued a decision of Substantially Equivalent on Jun 19, 2019. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Adherium (Nz), Ltd. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 19, 2019
- Date Received
- Sep 24, 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)