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

Name: FDA 510(k) clearance K851628
Creator: U.S. Food and Drug Administration
Published: 1985-06-27

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. Device class: 2.

Clearance details

Applicant: Eaton Medical Group
Product code: Code DXJ
Device class: Class 2
Regulation: 21 CFR 870.2450
Advisory panel: Cardiovascular
Date received: 1985-04-18
Decision date: 1985-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eaton, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Eaton Medical Group

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K851623 — MODEL TRC-40 TELEMETRY RECIEVER MODULE1986-01-22
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K851625 — SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-20001985-11-19
K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR1985-11-08
K851632 — PCX-100 PATIENT INPUT LEADWIRE1985-11-08

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.