NERVE STIMULATORS— 510(k) K771237

Name: FDA 510(k) clearance K771237
Creator: U.S. Food and Drug Administration
Published: 1977-08-02

Substantially Equivalent

Rule Medical Instruments, Inc.

FDA 510(k) clearance K771237 for NERVE STIMULATORS, Substantially Equivalent on 1977-08-02. Applicant: Rule Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Rule Medical Instruments, Inc.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1977-07-11
Decision date: 1977-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Rule Medical Instruments, Inc.

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K791199 — ANESTHESIA OXYGEN ANALYZER MODEL 1011979-08-03
K782074 — VENTILATOR, MODEL AVA-1, ADULT1978-12-21
K771217 — ANESTHESIA RESPIRATOR1977-08-04

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.