510(k) K982396
K982396 is an FDA 510(k) premarket notification submitted by Rsq, LLC for the device "VISIVOX, MODEL V-2". The FDA issued a decision of Substantially Equivalent on September 14, 1998. 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
- September 14, 1998
- Date Received
- July 9, 1998
- 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