Inteliclinic · 89-08 · POLAND
For Inteliclinic, import alert is 89-08; country is POLAND; 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 Sleep Mask | Sleep Mask; product code is 84 D - - QA Cranial Motion Measurement Device | 84 O - - LZ automatic event detection software for polysomnograph with electroencephalograph; date published is 11/16/2016; address is Ul. Wladyslawa Niegolewskiego 17 , Warsaw, Mazowieckie POLAND, verified against its source on 2026-09-30.
- Firm
- Inteliclinic 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
- POLAND verified
- Address
- Ul. Wladyslawa Niegolewskiego 17 , Warsaw, Mazowieckie POLAND verified
- Date published
- 11/16/2016 verified
- Product code
- 84 D - - QA Cranial Motion Measurement Device | 84 O - - LZ automatic event detection software for polysomnograph with electroencephalograph each item verified
- Product
- Sleep Mask | Sleep Mask each item verified
What the source says
Inteliclinic Date Published : 11/16/2016 Ul. Wladyslawa Niegolewskiego 17 , Warsaw, Mazowieckie POLAND
— 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
84 D - - QA Cranial Motion Measurement Device Date Published: 11/16/2016 Desc: Sleep Mask 84 O - - LZ automatic event detection software for polysomnograph with electroencephalograph Date Published: 11/16/2016 Desc: Sleep Mask
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html