NOVAMETRIX MODEL 200 MAGSTIM— 510(k) K871338

Substantially Equivalent

Novametrix Medical Systems, Inc.

FDA 510(k) clearance K871338 for NOVAMETRIX MODEL 200 MAGSTIM, Substantially Equivalent on 1987-08-04. Applicant: Novametrix Medical Systems, Inc..

Clearance details

Applicant: Novametrix Medical Systems, Inc.
Product code: Code GWF
Advisory panel: Neurology
Date received: 1987-04-03
Decision date: 1987-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.