PERIPHERAL NERVE STIMULATOR, MODEL A-200— 510(k) K822157

Name: FDA 510(k) clearance K822157
Creator: U.S. Food and Drug Administration
Published: 1982-07-30

Substantially Equivalent

P.B. Services

FDA 510(k) clearance K822157 for PERIPHERAL NERVE STIMULATOR, MODEL A-200, Substantially Equivalent on 1982-07-30. Applicant: P.B. Services. Device class: 2.

Clearance details

Applicant: P.B. Services
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1982-07-23
Decision date: 1982-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K162086 — MultiStim ECO2017-01-06
K153045 — SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator2016-05-13
K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator2015-03-24
K140853 — STIMPOD ST2-3010 NERVE STIMULATOR2014-11-06

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.