510(k) K934805
- Device
- HEARIT
- Applicant
- Je Liss & Co., Inc.
- 510(k) number
- K934805
- Product code
- LZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-07
- Date received
- 1993-10-07
- Regulation
- 874.3320
- Classification name
- Device, Assistive Listening
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- LORIN W SURPLESS
- Address
- 5665 N. Camino Estrellas Tucson AZ US 85718 85718
FDA Registration Numbers#
- 3030220356
- 3002808415
- 3008848788
- 3005085999
- 3026940243
- 3006312495
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K043090 | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | Phonic Ear, Inc. | 2004-12-23 |
| K970974 | WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER | Williams Sound, LLC | 1997-05-02 |
| K970340 | AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER | Bellab | 1997-03-26 |
| K954748 | POCKETALKER PRO | Williams Sound, LLC | 1995-11-22 |
| K952057 | LISTENAIDER II | National Hearing Aid Dist., Inc. | 1995-06-21 |
| K904755 | ACOUSTIQ LISTENING DEVICE | Krueger Laboratories | 1991-01-29 |