510(k) K053466
K053466 is an FDA 510(k) premarket notification submitted by Hsiner Co., Ltd. for the device "HSINER RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on March 22, 2006. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Hsiner Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 2006
- Date Received
- December 13, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type