Data / Medical devices / United Kingdom / Deltex Medical Limited
Deltex Medical Limited: FDA-registered device maker in CHICHESTER West Sussex, United Kingdom, 5 510(k) clearances
Deltex Medical Limited is registered with the FDA (registration 9680933) in CHICHESTER West Sussex, United Kingdom. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 22, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680933
- FEI number
- 1000637007
- Address
- Terminus RD., CHICHESTER West Sussex, United Kingdom, PO19 8TX
- Owner or operator
- Deltex Medical (9012472)
- Roles
- Manufacturer
- First device listed
- April 4, 2005
- Registered through
- 2026
- Brand names listed
- CardioQ & CardioQ-EDM Roll Stand, CardioQ-EDM Cardiac Function and Fluid Status Monitoring Sys, CardioQ-EDM+ Cardiac Function and Fluid Status Monitoring System, DP240 (9070-7006), I2C Doppler Probe (72 hour), I2P Doppler Probe (24 hour), I2S Doppler Probe (6 hour), KDP72 Doppler Probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer | accessdata.fda.gov |
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Manufacturer | accessdata.fda.gov |
| Probe, Blood-Flow, Extravascular | DPT | 2 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 22, 2015 | K142932 | Deltex Medical KDP72 Doppler Probe | DPT | Substantially Equivalent | Deltex Medical Limited | accessdata.fda.gov |
| October 10, 2013 | K132139 | DELTEX MEDICAL CARDIOQ-EDM+ | DPW | Substantially Equivalent | Deltex Medical Limited | accessdata.fda.gov |
| October 20, 2011 | K111542 | DELTEX MEDICAL CARDIOQ EDM | DPW | Substantially Equivalent | Deltex Medical Limited | accessdata.fda.gov |
| January 29, 2009 | K073593 | I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 | DPT | Substantially Equivalent | Deltex Medical Limited | accessdata.fda.gov |
| March 8, 2006 | K052989 | DP240 240 HOUR DOPPLER PROBE | DPT | Substantially Equivalent | Deltex Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Probe, Blood-Flow, Extravascular
- All makers of Stand, Infusion
- All makers of Flowmeter, Blood, Cardiovascular
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
Updated January 22, 2015. 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.