510(k) K171397
K171397 is an FDA 510(k) premarket notification submitted by Ems Handels Gesellschaft M.B.H. for the device "Sienna Ultimate Wireless Amplifier". The FDA issued a decision of Substantially Equivalent on October 6, 2017. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2017
- Date Received
- May 11, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type