510(k) K970340
K970340 is an FDA 510(k) premarket notification submitted by Bellab for the device "AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER". The FDA issued a decision of Substantially Equivalent on March 26, 1997. 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
- March 26, 1997
- Date Received
- January 29, 1997
- 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