PERIPHERAL NERVE STIMULATOR— 510(k) K760614

Name: FDA 510(k) clearance K760614
Creator: U.S. Food and Drug Administration
Published: 1976-11-19

Substantially Equivalent

Output, Inc.

FDA 510(k) clearance K760614 for PERIPHERAL NERVE STIMULATOR, Substantially Equivalent on 1976-11-19. Applicant: Output, Inc.. Device class: 2.

Clearance details

Applicant: Output, Inc.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1976-09-10
Decision date: 1976-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator2015-03-24
K140853 — STIMPOD ST2-3010 NERVE STIMULATOR2014-11-06

More clearances from Output, Inc.

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K800360 — OUTPUT DIGITAL DISPLAY MODULE, MOD. 6111980-02-29
K781115 — PRINTER, DIGITAL1978-10-06
K780356 — OUTPUT DIGITAL DISPLAY MODULE, MODEL 4011978-05-31
K770987 — NERVE STIMULATOR, MOLEL NO. FB-8001977-06-14

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.