510(k) K102625
K102625 is an FDA 510(k) premarket notification submitted by Vega Technologies, Inc. for the device "VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03". The FDA issued a decision of Substantially Equivalent on June 10, 2011. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Vega Technologies, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2011
- Date Received
- September 13, 2010
- 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