# Datrend Systems Inc. · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** CANADA _(verified: appears in the quote below)_
- **Address:** 5355 Parkwood Pl , Richmond, British Columbia CANADA _(verified: appears in the quote below)_
- **Date published:** 03/20/2012 _(verified: appears in the quote below)_
- **Product code:** 74 D - - PS Electrocardiograph | 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) _(verified: each item appears in the quote below)_
- **Product:** ECG Arrhythmia Simulator Model 10A and 20A | ECG Arrhythmia Simulator Model 10A and 20A _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## 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

## 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/).