510(k) K153387
K153387 is an FDA 510(k) premarket notification submitted by 3B Medical, Inc. for the device "Luna CPAP and Auto CPAP System". The FDA issued a decision of Substantially Equivalent on September 8, 2016. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. 3B Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2016
- Date Received
- November 23, 2015
- 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