DUAL CHENNEL BRAIN ACTIVITY MONITOR— 510(k) K843808

Clearance details

Applicant

Datex Division Instrumentarium Corp.

Product code

Code OLT

Device class

Class 2

Regulation

21 CFR 882.1400

Advisory panel

Neurology

Date received

1984-09-27

Decision date

1984-11-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Helsinki 10 Finland, US

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Other

1

Total

1

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 →