510(k) K001137
K001137 is an FDA 510(k) premarket notification submitted by Trudell Medical Int'L for the device "AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)". The FDA issued a decision of Substantially Equivalent on Jul 5, 2000. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Trudell Medical Int'L has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 5, 2000
- Date Received
- Apr 10, 2000
- Clearance Type
- Special
- 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
- 510(k)