Data / Medical devices / United Kingdom / Digitimer Ltd.
Digitimer Ltd.: FDA-registered device maker in Welwyn Garden City Hertfordshire, United Kingdom, 3 510(k) clearances
Digitimer Ltd. is registered with the FDA (registration 3003631667) in Welwyn Garden City Hertfordshire, United Kingdom. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 6, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003631667
- Address
- 37 Hydeway, Welwyn Garden City Hertfordshire, United Kingdom, AL7 3BE
- Owner or operator
- DIGITIMER LTD. (9043315)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- December 3, 2007
- Registered through
- 2026
- Brand names listed
- Cuillin Nanolgger, D185 MultiPulse Cortical Stimulator, DS7AH Constant Current Stimulator, Digitimer DS7AP Constant Current Stimulator, Digitimer Urodynamics Catheters & Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Connector, Ureteral Catheter | EYK | 1 | Exporter to the US | accessdata.fda.gov |
| Cystometer, Electrical Recording | EXQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Miniature Pressure | IKE | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 6, 2018 | K172381 | Digitimer DS7AP Constant Current Stimulator | IPF | Substantially Equivalent | Digitimer , Ltd. | accessdata.fda.gov |
| September 20, 2005 | K051357 | DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH | GWF | Substantially Equivalent | Digitimer , Ltd. | accessdata.fda.gov |
| August 23, 2002 | K020400 | DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR | GWF | Substantially Equivalent | Meps, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Miniature Pressure
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Stimulator, Muscle, Powered
- All makers of Cystometer, Electrical Recording
- All makers of Connector, Ureteral Catheter
Updated March 6, 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.