510(k) K101685 ยท DRX Electrode, Electrocardiograph
IP-SET
| Applicant | Integral Process Sas, Conflans Sainte Honorine, FR |
| Decision | Substantially Equivalent, Jul 1, 2010 |
| Received | Jun 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2022 | Graphic Controls Acquisition Corporation CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US
Model: 32028776 50401-US Terminated |
DRX | None listed |
| Mar 15, 2022 | Graphic Controls Acquisition Corporation CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US
Model: 32028777 50600 US Terminated |
DRX | None listed |
| Mar 15, 2022 | Graphic Controls Acquisition Corporation CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US
Model: 32028778 50601-US Terminated |
DRX | None listed |
| Mar 15, 2022 | Graphic Controls Acquisition Corporation CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US
Model: 32028779 50602-US Terminated |
DRX | None listed |
| Mar 15, 2022 | Graphic Controls Acquisition Corporation CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US
Model: 32028780 50603-US Terminated |
DRX | None listed |
| Mar 15, 2022 | Graphic Controls Acquisition Corporation CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT
Model: 32028781 50604-US Terminated |
DRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.