Tomatis Electronics · 89-08 · FRANCE
For Tomatis Electronics, import alert is 89-08; country is FRANCE; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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