510(k) K111570
K111570 is an FDA 510(k) premarket notification submitted by Thayer Medical Corporation for the device "MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR". The FDA issued a decision of Substantially Equivalent on September 29, 2011. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Thayer Medical Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2011
- Date Received
- June 6, 2011
- 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