510(k) K954748
K954748 is an FDA 510(k) premarket notification submitted by Williams Sound, LLC for the device "POCKETALKER PRO". The FDA issued a decision of Substantially Equivalent on November 22, 1995. The device falls under product code LZI (Device, Assistive Listening), a Class II device regulated under 21 CFR 874.3320. Williams Sound, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1995
- Date Received
- October 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Assistive Listening
- Device Class
- Class II
- Regulation Number
- 874.3320
- Review Panel
- EN
- Submission Type