Parasym OU · 89-08 · ESTONIA
For Parasym OU, import alert is 89-08; country is ESTONIA; 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 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 2026-09-30.
- 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
What the source says
Parasym OU Date Published : 09/11/2023 Majaka 26, 11412 , Tallinn, ESTONIA
— 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 Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html