Datrend Systems Inc. · 89-08 · CANADA
For Datrend Systems Inc., 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html