Datrend Systems Inc. · 89-08 · CANADA
For Datrend Systems Inc. · 89-08 · CANADA, 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 CANADA; product is ECG Arrhythmia Simulator Model 10A and 20A | ECG Arrhythmia Simulator Model 10A and 20A; product code is 74 D - - PS Electrocardiograph | 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); date published is 03/20/2012; address is 5355 Parkwood Pl , Richmond, British Columbia CANADA, verified against its source on 2026-09-16.
- Firm
- Datrend Systems Inc. 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
- 5355 Parkwood Pl , Richmond, British Columbia CANADA verified
- Date published
- 03/20/2012 verified
- Product code
- 74 D - - PS Electrocardiograph | 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) each item verified
- Product
- ECG Arrhythmia Simulator Model 10A and 20A | ECG Arrhythmia Simulator Model 10A and 20A each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Datrend Systems Inc. Date Published : 03/20/2012 5355 Parkwood Pl , Richmond, British Columbia CANADA 74 D - - PS Electrocardiograph Date Published: 03/20/2012 Desc: ECG Arrhythmia Simulator Model 10A and 20A Notes: Class II 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Date Published: 03/20/2012 Desc: ECG Arrhythmia Simulator Model 10A and 20A Notes: Class II
— 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.