Data / Medical devices / United Kingdom / Camntech
Camntech: FDA-registered device maker in Fenstanton Cambridgeshire, United Kingdom, 2 510(k) clearances
Camntech is registered with the FDA (registration 3007485597) in Fenstanton Cambridgeshire, United Kingdom. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 21, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007485597
- Address
- Manor Farm, Fenstanton Cambridgeshire, United Kingdom, PE289JD
- Owner or operator
- CamNtech (10028414)
- Roles
- Manufacturer
- First device listed
- January 28, 2009
- Registered through
- 2026
- Brand names listed
- Actiheart, MotionWatch, MotionWatch 8, PRO-Diary
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Conditioner, Signal, Physiological | GWK | 2 | Manufacturer | accessdata.fda.gov |
| Device, Sleep Assessment | LEL | 2 | 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 21, 2014 | K132764 | MOTION WATCH AND PRO-DIARY | LEL | Substantially Equivalent | Camntech, Ltd. | accessdata.fda.gov |
| September 27, 2005 | K052489 | ACTIHEART | GWK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 21, 2014. 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.