Savec Health Systems · 89-08 · UNITED KINGDOM
For Savec Health Systems, import alert is 89-08; country is UNITED KINGDOM; 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 73 C - - AW Generator, Oxygen, Portable; date published is 09/16/2009; address is 120 Deramore Avenue , Northern Ireland , Belfast, Nir UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Savec Health Systems 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
- UNITED KINGDOM verified
- Address
- 120 Deramore Avenue , Northern Ireland , Belfast, Nir UNITED KINGDOM verified
- Date published
- 09/16/2009 verified
- Product code
- 73 C - - AW Generator, Oxygen, Portable verified
- FDA notes
- Omnivir Device Possibly listed as oxygen generator 12/17/2008 verified
What the source says
Savec Health Systems Date Published : 09/16/2009 120 Deramore Avenue , Northern Ireland , Belfast, Nir UNITED KINGDOM
— 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
73 C - - AW Generator, Oxygen, Portable Date Published: 09/16/2009 Notes: Omnivir Device Possibly listed as oxygen generator 12/17/2008
— 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.