AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
FDA 510(k) clearance K970340 · decided 1997-03-26
Clearance details
- K-number
- K970340
- Device name
- AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
- Applicant
- Bellab
- Decision
- Substantially Equivalent
- Date received
- 1997-01-29
- Decision date
- 1997-03-26
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LZI
- Device class
- 2
- Regulation number
- 874.3320
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Gothenburg, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (K043090) | Phonic Ear, Inc. | 2004-12-23 |
| WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER (K970974) | Williams Sound, LLC | 1997-05-02 |
| POCKETALKER PRO (K954748) | Williams Sound, LLC | 1995-11-22 |
| LISTENAIDER II (K952057) | National Hearing Aid Dist., Inc. | 1995-06-21 |
| HEARIT (K934805) | Je Liss & Co., Inc. | 1994-02-07 |
| ACOUSTIQ LISTENING DEVICE (K904755) | Krueger Laboratories | 1991-01-29 |
Recalls involving this device
No recalls on record reference this clearance.