NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS— 510(k) K980380

Substantially Equivalent

Diametrics Medical, Ltd.

FDA 510(k) clearance K980380 for NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS, Substantially Equivalent on 1999-07-14. Applicant: Diametrics Medical, Ltd..

Clearance details

Applicant: Diametrics Medical, Ltd.
Product code: Code GWM
Advisory panel: Neurology
Date received: 1998-02-02
Decision date: 1999-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: High Wycombe, Buckinghamshire, GB

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Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.