510(k) K781522
K781522 is an FDA 510(k) premarket notification submitted by Exeter Medical Labs, Inc. for the device "THE VISUAL SPEECH AID". The FDA issued a decision of Substantially Equivalent on November 8, 1978. The device falls under product code LFA (Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)), a Class U device. Exeter Medical Labs, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1978
- Date Received
- September 5, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type