510(k) K934805
K934805 is an FDA 510(k) premarket notification submitted by Je Liss & Co., Inc. for the device "HEARIT". The FDA issued a decision of Substantially Equivalent on February 7, 1994. The device falls under product code LZI (Device, Assistive Listening), a Class II device regulated under 21 CFR 874.3320.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1994
- Date Received
- October 7, 1993
- 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