510(k) K203746
K203746 is an FDA 510(k) premarket notification submitted by Shenzhen Pango Electronic Co., Ltd. for the device "Venen-trainer (Model: FM150, SFM90)". The FDA issued a decision of Substantially Equivalent on Nov 10, 2021. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Shenzhen Pango Electronic Co., Ltd. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 10, 2021
- Date Received
- Dec 22, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type
- 510(k)