Acoustiq Listening Device
FDA 510(k) K904755 · Krueger Laboratories
510(k) numberK904755
Submission
- Device name
- Acoustiq Listening Device
- Applicant
- Krueger Laboratories
Tempe, AZ, US - Received
- October 19, 1990
- Decision date
- January 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LZI – Device, Assistive Listening
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3320
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043090 | Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field SystemsLZI · Traditional | Phonic Ear, Inc. | 12/23/2004SE |
| K970974 | Williams Sound, Personal FM System, Hearing HelperLZI · Traditional | Williams Sound, LLC | 05/02/1997SE |
| K970340 | Air Conduction Assistive Listening Device.Personal AmplifierLZI · Traditional | Bellab | 03/26/1997SE |
| K954748 | Pocketalker ProLZI · Traditional | Williams Sound, LLC | 11/22/1995SE |
| K952057 | Listenaider IILZI · Traditional | National Hearing Aid Dist., Inc. | 06/21/1995SE |
| K934805 | HearitLZI · Traditional | Je Liss & Co., Inc. | 02/07/1994SE |
Questions and answers
When was Acoustiq Listening Device cleared by the FDA?
Acoustiq Listening Device (K904755) received a 510(k) decision of Substantially Equivalent on January 29, 1991, 102 days after the submission was received.
What is the product code of K904755?
The FDA product code is LZI – Device, Assistive Listening, a Class II (moderate risk) device regulated under 21 CFR 874.3320.