BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)— 510(k) K002565

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K002565 for BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE), Substantially Equivalent on 2001-05-03. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code GXD
Advisory panel: Neurology
Date received: 2000-08-17
Decision date: 2001-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

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.