510(k) K052811
K052811 is an FDA 510(k) premarket notification submitted by Hsiner Co., Ltd. for the device "HSINER JET NEBULIZER, MODEL HS-31100". The FDA issued a decision of Substantially Equivalent on December 21, 2005. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Hsiner Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2005
- Date Received
- October 4, 2005
- 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