Ondamed GmBH · 89-08 · GERMANY
For Ondamed GmBH, import alert is 89-08; country is GERMANY; 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 H - - CC Device, Biofeedback; date published is 09/16/2009; address is Kurzeller Str. 18 , Schwanau, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-30.
- Firm
- Ondamed GmBH 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
- GERMANY verified
- Address
- Kurzeller Str. 18 , Schwanau, Baden-Wurttemberg GERMANY verified
- Date published
- 09/16/2009 verified
- Product code
- 84 H - - CC Device, Biofeedback verified
- FDA notes
- Ondamed System Regulation Biofeedback Device 4/29/2003 verified
What the source says
Ondamed GmBH Date Published : 09/16/2009 Kurzeller Str. 18 , Schwanau, Baden-Wurttemberg GERMANY
— 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 H - - CC Device, Biofeedback Date Published: 09/16/2009 Notes: Ondamed System Regulation Biofeedback Device 4/29/2003
— 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.