510(k) K091682
K091682 is an FDA 510(k) premarket notification submitted by Lsvt Global, LLC for the device "LSVT C OR LSVT COMPANION, MODEL V.1". The FDA issued a decision of Substantially Equivalent on August 20, 2009. The device falls under product code LEZ (Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2009
- Date Received
- June 10, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type