SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT— 510(k) K912070

Substantially Equivalent

Siemens Medical Electronics

FDA 510(k) clearance K912070 for SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT, Substantially Equivalent on 1992-04-23. Applicant: Siemens Medical Electronics.

Clearance details

Applicant: Siemens Medical Electronics
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1991-05-10
Decision date: 1992-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.