510(k) K140929
K140929 is an FDA 510(k) premarket notification submitted by Human Design Medical, LLC for the device "Z1 CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 17, 2014. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2014
- Date Received
- April 9, 2014
- 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