SERVOMED MEDIVISION SCOPE SMV-235— 510(k) K840209

Name: FDA 510(k) clearance K840209
Creator: U.S. Food and Drug Administration
Published: 1984-09-20

Substantially Equivalent

Litton Medical Electronics

FDA 510(k) clearance K840209 for SERVOMED MEDIVISION SCOPE SMV-235, Substantially Equivalent on 1984-09-20. Applicant: Litton Medical Electronics. Device class: 2.

Clearance details

Applicant: Litton Medical Electronics
Product code: Code DXJ
Device class: Class 2
Regulation: 21 CFR 870.2450
Advisory panel: Cardiovascular
Date received: 1984-01-19
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K840522 — RECOMED BLOOD-FLOW METER H236-052-021985-05-16
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K840899 — SERVOMED ARRHYCOMP CENTRAL MONITOR SYS1984-11-20
K840523 — SERVOMED PULSE AMPLIFIER MODULE-206-1984-10-29
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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.