510(k) K180388
K180388 is an FDA 510(k) premarket notification submitted by Somnetics International, Inc. for the device "Transcend 365 miniCPAP System". The FDA issued a decision of Substantially Equivalent on Nov 30, 2018. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Somnetics International, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 30, 2018
- Date Received
- Feb 13, 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
- 510(k)