DeviceClearance

RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO— 510(k) K851628

Substantially Equivalent

Eaton Medical Group

FDA 510(k) clearance K851628 for RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO, Substantially Equivalent on 1985-06-27. Applicant: Eaton Medical Group.

Clearance details

Applicant
Eaton Medical Group
Product code
Code DXJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eaton, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DXJ

product code DXJ
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.