Tomatis Electronics · 89-08 · FRANCE
For Tomatis Electronics · 89-08 · FRANCE, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is FRANCE; product code is 84 G - - WJ Stimulator, Auditory, Evoked Response; date published is 09/16/2009; address is 56 Rue Des Batignolles , Paris, Paris FRANCE, verified against its source on 2026-09-16.
- Firm
- Tomatis Electronics verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- FRANCE verified
- Address
- 56 Rue Des Batignolles , Paris, Paris FRANCE verified
- Date published
- 09/16/2009 verified
- Product code
- 84 G - - WJ Stimulator, Auditory, Evoked Response verified
- FDA notes
- Electronic Ear; or any device labeled or marked for auditory training; auditory integration or behavioral improvement. verified
What the source says
Tomatis Electronics Date Published : 09/16/2009 56 Rue Des Batignolles , Paris, Paris FRANCE 84 G - - WJ Stimulator, Auditory, Evoked Response Date Published: 09/16/2009 Notes: Electronic Ear; or any device labeled or marked for auditory training; auditory integration or behavioral improvement.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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