SPECTRAL EEG MONITOR MODEL A1000— 510(k) K923043

Name: FDA 510(k) clearance K923043
Creator: U.S. Food and Drug Administration
Published: 1992-12-03

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K923043 for SPECTRAL EEG MONITOR MODEL A1000, Substantially Equivalent on 1992-12-03. Applicant: Aspect Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Aspect Medical Systems, Inc.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1992-06-24
Decision date: 1992-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Framingham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLT

product code OLT

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.