Comptronics Devices Limited · 89-08 · CANADA
For Comptronics Devices Limited, import alert is 89-08; country is CANADA; 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 code is 84 J - - XK Cranial electrotherapy stimulator to treat depression; date published is 09/16/2009; address is 9008 51 Ave NW , Edmonton, Alberta CANADA, verified against its source on 2026-09-30.
- Firm
- Comptronics Devices Limited 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
- CANADA verified
- Address
- 9008 51 Ave NW , Edmonton, Alberta CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 84 J - - XK Cranial electrotherapy stimulator to treat depression verified
- FDA notes
- 6/29/2000 Oasis Cranial Electrotherapy Stimulator (CES) verified
What the source says
Comptronics Devices Limited Date Published : 09/16/2009 9008 51 Ave NW , Edmonton, Alberta CANADA
— 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 FDA notes
84 J - - XK Cranial electrotherapy stimulator to treat depression Date Published: 09/16/2009 Notes: 6/29/2000 Oasis Cranial Electrotherapy Stimulator (CES)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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