Inteliclinic · 89-08 · POLAND
For Inteliclinic · 89-08 · POLAND, 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 POLAND; 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 2026-09-16.
- 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 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
— 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.