Ondamed GmBH · 89-08 · GERMANY
For Ondamed GmBH · 89-08 · GERMANY, 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 GERMANY; 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 2026-09-16.
- 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 84 H - - CC Device, Biofeedback Date Published: 09/16/2009 Notes: Ondamed System Regulation Biofeedback Device 4/29/2003
— 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.