510(k) K180497
K180497 is an FDA 510(k) premarket notification submitted by Resmed, Ltd. for the device "Scone Mask". The FDA issued a decision of Substantially Equivalent on June 15, 2018. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Resmed, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2018
- Date Received
- February 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type