Esaote Biomedica SpA
Cambridge, MA, US
Esaote Biomedica Spa appears in FDA device records in Cambridge, MA. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Esaote Biomedica SpA between 1990 and 1994. The busiest year on record is 1990, with 3. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 3 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K933951 | VIDEO EEG OPTION MODIFICATION | GWQ | Substantially Equivalent | |
| K902368 | PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K896356 | AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM | IYO | Substantially Equivalent | |
| K902334 | MONITOR, MODEL 2817 | DXJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0535-04 | Esaote brand Formul@ ECG System; part 9704220000. | If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient. | Terminated | ||
| Z-0534-04 | Esaote brand ArchiWin Colour ECG System; part 9704325000. | If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient. | Terminated | ||
| Z-0533-04 | Esaote brand Formula for Archimed ECG System; part 9704220000. | If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient. | Terminated | ||
| Z-0532-04 | Esaote brand Archimed 4220 ECG System; part 9704220000. | If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain