Esaote Biomedica SpA
Country not established
- Devices
- 4
What Esaote Biomedica SpA makes
Esaote Biomedica Spa manufactures electrocardiograph systems, including portable units for basic cardiac monitoring, and diagnostic ultrasound equipment for pulsed-echo imaging. Their product line also includes EEG monitoring modifications and medical monitoring devices, such as the Model 2817 monitor.
These devices are classified as Class II under FDA regulations, with authorisation records maintained through the 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations.
Catalogue
Video Eeg Option Modification Ref K933951
Regimes: 510(k) Registry: 510(k)Monitor, Model 2817 Ref K902334
Regimes: 510(k) Registry: 510(k)AU530 Diagnostic Ultrasonic Pulsed Echo System Ref K896356
Regimes: 510(k) Registry: 510(k)Personal 120/210 Basic Electrocardiograph Ref K902368
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Esaote Biomedica Spa have in the registry?
The registry currently lists 4 devices for Esaote Biomedica Spa. Devices recorded under merged duplicate company entries are counted once.
Which registries list Esaote Biomedica Spa's devices?
Among its 4 most recently registered devices, Esaote Biomedica Spa has devices listed in FDA 510(k) (4 devices).
What risk classes do Esaote Biomedica Spa's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Esaote Biomedica Spa's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Esaote Biomedica Spa in the registry?
The most recently registered devices listed for Esaote Biomedica Spa include VIDEO EEG OPTION MODIFICATION, MONITOR, MODEL 2817, AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM and PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH.