SERVOMED SMC 108/111-426-24, 111-426— 510(k) K832022

Clearance details

Applicant

Litton Medical Electronics

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

1983-06-23

Decision date

1983-11-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K840522 — RECOMED BLOOD-FLOW METER H236-052-021985-05-16
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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 →