MYOTEST DBS NERVE STIMULATOR— 510(k) K890746

Substantially Equivalent

Biometer Intl. A/S

FDA 510(k) clearance K890746 for MYOTEST DBS NERVE STIMULATOR, Substantially Equivalent on 1989-07-14. Applicant: Biometer Intl. A/S.

Clearance details

Applicant: Biometer Intl. A/S
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 1989-02-13
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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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.