MANDELAY KFT · 89-08 · HUNGARY
For MANDELAY KFT · 89-08 · HUNGARY, 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 HUNGARY; product is The Quantum Xrroid Consciousness/Medical Interface System Unclassified; product code is 84 H - - CC Device, Biofeedback | 84 - - - -- Neurological; date published is 01/23/2019; address is Huba Utca 25-2 , Tokol, Pest HUNGARY, verified against its source on 2026-09-16.
- Firm
- MANDELAY KFT 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
- HUNGARY verified
- Address
- Huba Utca 25-2 , Tokol, Pest HUNGARY verified
- Date published
- 01/23/2019 verified
- Product code
- 84 H - - CC Device, Biofeedback | 84 - - - -- Neurological each item verified
- Product
- The Quantum Xrroid Consciousness/Medical Interface System Unclassified verified
- FDA notes
- Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008. | 6/28/2002 each item verified
What the source says
MANDELAY KFT Date Published : 01/23/2019 Huba Utca 25-2 , Tokol, Pest HUNGARY 84 H - - CC Device, Biofeedback Date Published: 05/06/2021 Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008. 84 - - - -- Neurological Date Published: 01/23/2019 Desc: The Quantum Xrroid Consciousness/Medical Interface System Unclassified Notes: 6/28/2002
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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