510(k) K970974
- Device
- WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER
- Applicant
- WILLIAMS SOUND, LLC
- 510(k) number
- K970974
- Product code
- LZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-02
- Date received
- 1997-03-17
- 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
- No
Applicant Contact#
- Contact
- PAUL INGEBRIGTSEN
- Address
- 10300 Valley View Rd. Eden Prairie MN US 55344 55344
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 |
| 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 |
| K934805 | HEARIT | Je Liss & Co., Inc. | 1994-02-07 |
| K904755 | ACOUSTIQ LISTENING DEVICE | Krueger Laboratories | 1991-01-29 |
Legacy Summary#
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FDA Review#
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