510(k) K102454
K102454 is an FDA 510(k) premarket notification submitted by Respironics Respiratory Drug Delivery (Uk) , Ltd. for the device "I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 25, 2011. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Respironics Respiratory Drug Delivery (Uk) , Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 2011
- Date Received
- Aug 27, 2010
- 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
- 510(k)