510(k) K002831
K002831 is an FDA 510(k) premarket notification submitted by Vega Technologies, Inc. for the device "VEGA ULTRASONIC NEBULIZER". The FDA issued a decision of Substantially Equivalent on May 23, 2001. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Vega Technologies, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2001
- Date Received
- September 11, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type