510(k) K032669
K032669 is an FDA 510(k) premarket notification submitted by Yeou Eir Shuen Machinery Co., Ltd. for the device "Y.E.S. POWERED WHEELCHAIR, MODEL T200". The FDA issued a decision of Substantially Equivalent on November 12, 2003. The device falls under product code ITN (Splint, Denis Brown), a Class I device regulated under 21 CFR 890.3675. Yeou Eir Shuen Machinery Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2003
- Date Received
- August 28, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Denis Brown
- Device Class
- Class I
- Regulation Number
- 890.3675
- Review Panel
- PM
- Submission Type