510(k) K071073 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, May 11, 2007 |
| Received | Apr 16, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071073
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2021 | GE Healthcare, LLC CARESCAPE PDM-Masimo SpO2. Physiological data monitor. Open, Classified |
MHX | None listed |
| Jun 24, 2020 | GE Healthcare, LLC CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers:
2042084-001
2094504-001
2042084-001-046050
2042084-001-2 Open, Classified |
MHX | None listed |
| Aug 31, 2018 | GE Healthcare, LLC Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | None listed |
| Jul 13, 2017 | GE Medical Systems Information Technologies, Inc. CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software
The PDM is intended to provide uninterrupted acquisition of physiologic p Terminated |
MHX | None listed |
| Oct 9, 2014 | GE Healthcare, LLC GE Healthcare Carescape Patient Data Module Terminated |
MHX | None listed |
| Mar 6, 2014 | GE Healthcare, LLC GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled.
The Solar 8000i with Patient Data Module / Transp Terminated |
MHX | None listed |
| Feb 26, 2014 | Cardiovascular Systems, Inc. CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125
Product Usage: The system is indicated to facilitate stent delivery in patients with coronary ar Terminated |
MCX | None listed |
| Jan 22, 2014 | GE Healthcare, LLC SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquis Terminated |
MHX | None listed |
| Jan 14, 2014 | GE Healthcare, LLC GE Healthcare Carescape Patient Data Module
The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients dur Terminated |
MHX | None listed |
| Jan 9, 2014 | GE Healthcare, LLC SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Terminated |
MHX | None listed |
| Aug 28, 2013 | GE Healthcare, LLC SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
(Marketed As GE Healthcare CARESCAPE Patient Data Module)
Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acqu Terminated |
MHX | None listed |
| Dec 14, 2012 | GE Healthcare, LLC GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiolo Terminated |
MHX | None listed |
| Nov 15, 2010 | GE Healthcare, LLC GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.