T4 MONITOR STIMULATOR COMPUTER— 510(k) K853476

Name: FDA 510(k) clearance K853476
Creator: U.S. Food and Drug Administration
Published: 1986-01-14

Substantially Equivalent

Regional Master Corp.

FDA 510(k) clearance K853476 for T4 MONITOR STIMULATOR COMPUTER, Substantially Equivalent on 1986-01-14. Applicant: Regional Master Corp.. Device class: 2.

Clearance details

Applicant: Regional Master Corp.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1985-08-14
Decision date: 1986-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BXN

product code BXN

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.