Reference Source

Parasym OU · 89-08 · ESTONIA

For Parasym OU · 89-08 · ESTONIA, 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 ESTONIA; product is NUROSYM | NUROSYM | NUROSYM | NUROSYM | NUROSYM; product code is 73 B - - XM Stimulator, Nerve, Ac-Powered | 79 M - - DM Instrument, Manual, General Surgical | 84 L - - YJ Stimulator, Autonomic Nerve, Implanted for Epilepsy | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 P - - KR Non-invasive vagus nerve stimulator - headache; date published is 09/11/2023; address is Majaka 26, 11412 , Tallinn, ESTONIA, verified against its source on 2026-09-16.

Firm
Parasym OU 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
ESTONIA verified
Address
Majaka 26, 11412 , Tallinn, ESTONIA verified
Date published
09/11/2023 verified
Product code
73 B - - XM Stimulator, Nerve, Ac-Powered | 79 M - - DM Instrument, Manual, General Surgical | 84 L - - YJ Stimulator, Autonomic Nerve, Implanted for Epilepsy | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 P - - KR Non-invasive vagus nerve stimulator - headache each item verified
Product
NUROSYM | NUROSYM | NUROSYM | NUROSYM | NUROSYM each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Parasym OU Date Published : 09/11/2023 Majaka 26, 11412 , Tallinn, ESTONIA 73 B - - XM Stimulator, Nerve, Ac-Powered Date Published: 09/11/2023 Desc: NUROSYM 79 M - - DM Instrument, Manual, General Surgical Date Published: 09/11/2023 Desc: NUROSYM 84 L - - YJ Stimulator, Autonomic Nerve, Implanted for Epilepsy Date Published: 09/11/2023 Desc: NUROSYM 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 09/11/2023 Desc: NUROSYM 84 P - - KR Non-invasive vagus nerve stimulator - headache Date Published: 09/11/2023 Desc: NUROSYM

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

Source

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