The following data is part of a premarket notification filed by Bellab with the FDA for Air Conduction Assistive Listening Device.personal Amplifier.
| Device ID | K970340 |
| 510k Number | K970340 |
| Device Name: | AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER |
| Classification | Device, Assistive Listening |
| Applicant | BELLAB GUSTAF WERNERS GATA 2 S-421 32 V. FROLUNDA Gothenburg, SE |
| Contact | Martin Eriksson |
| Correspondent | Martin Eriksson BELLAB GUSTAF WERNERS GATA 2 S-421 32 V. FROLUNDA Gothenburg, SE |
| Product Code | LZI |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-29 |
| Decision Date | 1997-03-26 |
| Summary: | summary |