510(k) K031370
K031370 is an FDA 510(k) premarket notification submitted by Shining World Health Care Co., Ltd. for the device "SHINMED MODE SW-988 UNTRASONIC NEBULIZER". The FDA issued a decision of Substantially Equivalent on Sep 1, 2004. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Shining World Health Care Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 1, 2004
- Date Received
- Apr 30, 2003
- 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)