Product code LZI— Ear, Nose, Throat
ACOUSTIQ LISTENING DEVICE
- Classification name
- Device, Assistive Listening
- Device class
- Class 2
- Regulation
- 21 CFR 874.3320
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code LZI
FDA has cleared devices under product code LZI between 1991 and 2004, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2004
- 1997
- 1995
- 1994
- 1991
Top applicants under product code LZI
Recent clearances under product code LZI
- K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
- K970974 — WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER
- K970340 — AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
- K954748 — POCKETALKER PRO
- K952057 — LISTENAIDER II
- K934805 — HEARIT
- K904755 — ACOUSTIQ LISTENING DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.