510(k) K813057
K813057 is an FDA 510(k) premarket notification submitted by Sonic Systems, Inc. for the device "VIBRO-COM COMMUNICATOR #8827". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1981
- Date Received
- October 29, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Tactile
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type