Tomatis International · 89-08 · FRANCE
For Tomatis International, 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 6 Pl de la Republique Dominicaine , Paris, Paris FRANCE, verified against its source on 2026-09-30.
- Firm
- Tomatis International 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
- 6 Pl de la Republique Dominicaine , 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 deviced labled or marked for auditory training; auditory integration; or behavioral improvement. 2/5/1997 verified
What the source says
Tomatis International Date Published : 09/16/2009 6 Pl de la Republique Dominicaine , 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 deviced labled or marked for auditory training; auditory integration; or behavioral improvement. 2/5/1997
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.