Reference Source

Savec Health Systems · 89-08 · UNITED KINGDOM

For Savec Health Systems · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Savec Health Systems Date Published : 09/16/2009 120 Deramore Avenue , Northern Ireland , Belfast, Nir UNITED KINGDOM 73 C - - AW Generator, Oxygen, Portable Date Published: 09/16/2009 Notes: Omnivir Device Possibly listed as oxygen generator 12/17/2008

accessdata.fda.gov, retrieved 2026-09-15

Source

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