510(k) K955023 ยท DSI Detector And Alarm, Arrhythmia
BRENTWOOD PC-ECG
| Applicant | Brentwood Medical Products, Inc., Torrance CA, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Nov 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955023
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2011 | Brentwood Medical Technology Corp IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2
Product Usage: IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surfa Terminated |
DSI | None listed |
| Jul 14, 2011 | Brentwood Medical Technology Corp IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1, 8.3.2
IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms fro Terminated |
DSI | None listed |
| Jul 14, 2011 | Brentwood Medical Technology Corp IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0
IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface. Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.