510(k) K233415
K233415 is an FDA 510(k) premarket notification submitted by Remsleep Holdings for the device "DELTAWAVE Nasal Pillows System". The FDA issued a decision of Substantially Equivalent on July 2, 2024. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Remsleep Holdings has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2024
- Date Received
- October 10, 2023
- 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