LISS CRANIAL STIMULATOR MODEL SBL202-B— 510(k) K903654

Name: FDA 510(k) clearance K903654
Creator: U.S. Food and Drug Administration
Published: 1990-10-04

Substantially Equivalent

Medical Consultants Intl. , Ltd.

FDA 510(k) clearance K903654 for LISS CRANIAL STIMULATOR MODEL SBL202-B, Substantially Equivalent on 1990-10-04. Applicant: Medical Consultants Intl. , Ltd.. Device class: 2.

Clearance details

Applicant: Medical Consultants Intl. , Ltd.
Product code: Code QJQ
Device class: Class 2
Regulation: 21 CFR 882.5800
Advisory panel: Neurology
Date received: 1990-07-06
Decision date: 1990-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Rock, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K903654

K-number listed on FDA's recall record

Z-1600-2023 — Fisher Wallace Stimulator Models FW-100 and FW-200Class II·Ongoing·Fisher Wallace Laboratories Inc.·20230406

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K903654.

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