510(k) K053490
K053490 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "MERITS HEALTH PRODUCTS PORTABLE NEBULIZER". The FDA issued a decision of Substantially Equivalent on July 24, 2006. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Merits Health Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2006
- Date Received
- December 15, 2005
- Clearance Type
- Abbreviated
- 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