# Inteliclinic · 89-08 · POLAND — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Ul. Wladyslawa Niegolewskiego 17 , Warsaw, Mazowieckie POLAND _(verified: appears in the quote below)_
- **Date published:** 11/16/2016 _(verified: appears in the quote below)_
- **Product code:** 84 D - - QA Cranial Motion Measurement Device | 84 O - - LZ automatic event detection software for polysomnograph with electroencephalograph _(verified: each item appears in the quote below)_
- **Product:** Sleep Mask | Sleep Mask _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).