SOMATOSENSORY STIMULATOR— 510(k) K810482

Name: FDA 510(k) clearance K810482
Creator: U.S. Food and Drug Administration
Published: 1981-04-29

Substantially Equivalent

Amplaid USA, Inc.

FDA 510(k) clearance K810482 for SOMATOSENSORY STIMULATOR, Substantially Equivalent on 1981-04-29. Applicant: Amplaid USA, Inc.. Device class: 2.

Clearance details

Applicant: Amplaid USA, Inc.
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 1981-02-23
Decision date: 1981-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K861014 — AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)1986-08-20
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K810473 — MK6 ERA SYSTEM1981-04-29
K810481 — VISUAL PATTERN REVERSAL GEN. & PHOTIC S.1981-03-11
K802963 — 101, 151, 161 PORTABLE AUDIOMETERS1980-12-19

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.