Data / Medical devices / United States / Flash Global
Flash Global: FDA-registered device maker in Lockbourne, OH, United States, 3 510(k) clearances
Flash Global is registered with the FDA (registration 3012251275) in Lockbourne, OH, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012251275
- Address
- 5653 Creekside Pkwy, Lockbourne, OH, United States, 43137
- Owner or operator
- Flash Global (10051121)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- June 14, 2018
- Registered through
- 2026
- Brand names listed
- Capsule Vitals Plus Patient Monitoring System, SmartLinx Vitals Plus Patient Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Contract manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2018 | K180734 | SmartLinx Vitals Plus Patient Monitoring System | MWI | Substantially Equivalent | Capsule Technologie | accessdata.fda.gov |
| October 24, 2017 | K171751 | SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module | MWI | Substantially Equivalent | Capsule Technologie Sas | accessdata.fda.gov |
| September 17, 2015 | K151071 | SmartLinx Vitals Plus Patient Monitoring System | MWI | Substantially Equivalent | Capsule Technologie Sas | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Oximeter
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Updated August 8, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.