# Esaote Biomedica Spa

- Location (FDA's records): Cambridge, MA
- FDA decisions: 4 (1990–1994): 4 510(k) clearances
- Product codes: DPS (1), DXJ (1), GWQ (1), IYO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Biosound Esaote, Inc.: 1 (https://510kreport.com/company/biosound-esaote)
- Biosound, Inc.: 1 (https://510kreport.com/company/biosound)

## Its most-cited devices
- K902368: Personal 120/210 Basic Electrocardiograph (1990), cited by 1
- K896356: AU530 Diagnostic Ultrasonic Pulsed Echo System (1990), cited by 1

## Recent decisions
- K933951: Video Eeg Option Modification (Feb 3, 1994)
- K902368: Personal 120/210 Basic Electrocardiograph (Sep 11, 1990)
- K896356: AU530 Diagnostic Ultrasonic Pulsed Echo System (Aug 21, 1990)
- K902334: Monitor, Model 2817 (Jun 26, 1990)

Source page: https://510kreport.com/company/esaote-biomedica