510(k) K180555
K180555 is an FDA 510(k) premarket notification submitted by Jk Holding GmbH for the device "Ergoline Prestige 1600 Hybrid Performance". The FDA issued a decision of Substantially Equivalent on Oct 11, 2018. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Jk Holding GmbH has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 11, 2018
- Date Received
- Mar 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Booth, Sun Tan
- Device Class
- Class II
- Regulation Number
- 878.4635
- Review Panel
- SU
- Submission Type
- 510(k)