510(k) K192240 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
RAPIDPoint 500e Blood Gas System
| Applicant | Siemens Healthcare Diagnostics, Inc., Norowood MA, US |
| Decision | Substantially Equivalent, Mar 27, 2020 |
| Received | Aug 19, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2024 | Siemens Healthcare Diagnostics Inc Software version 5.3 in:
RAPIDPoint 500e Blood Gas System (USA)
Siemens Material Number: 11416751
RAPIDPoint 500e Blood Gas System (China) 11416752;
RAPIDPoint 500e Blood Gas System (Japan) 1141675 Open, Classified |
CHL | None listed |
| Dec 1, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPOINT 500e Blood Gas System Open, Classified |
JGS | None listed |
| Jun 1, 2022 | Siemens Healthcare Diagnostics Inc epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood
Product Siemens Open, Classified |
CHL | None listed |
| May 27, 2020 | Siemens Healthcare Diagnostics Inc RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778 Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.