Scole Engineering Co.
Country not established
- Devices
- 4
What Scole Engineering Co. makes
Scole Engineering Co. manufactures ECG recorders, including the SCOLE 300, ALTA III, ALTA II, and the Recording Unit Model 1445. These devices are designed for capturing and documenting electrocardiogram readings, primarily for clinical or diagnostic use.
The company’s products fall under FDA Class II medical devices and are listed via the 510(k) premarket notification process. The devices are regulated under US jurisdiction, with the manufacturer based in the United States.
Catalogue
Scole 300 Ecg Recorder Ref K923664
Regimes: 510(k) Registry: 510(k)Alta Iii Ecg Recorder Ref K822363
Regimes: 510(k) Registry: 510(k)Recording Unit, Model 1445 Ref K770829
Regimes: 510(k) Registry: 510(k)Alta Ii Ecg Recorder Ref K822362
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scole Engineering Co. have in the registry?
The registry currently lists 4 devices for Scole Engineering Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scole Engineering Co.'s devices?
Among its 4 most recently registered devices, Scole Engineering Co. has devices listed in FDA 510(k) (4 devices).
What risk classes do Scole Engineering Co.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Scole Engineering Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scole Engineering Co. in the registry?
The most recently registered devices listed for Scole Engineering Co. include SCOLE 300 ECG RECORDER, ALTA III ECG RECORDER, RECORDING UNIT, MODEL 1445 and ALTA II ECG RECORDER.