NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100— 510(k) K993643

Substantially Equivalent

Nexan Telemed , Ltd.

FDA 510(k) clearance K993643 for NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100, Substantially Equivalent on 1999-12-28. Applicant: Nexan Telemed , Ltd..

Clearance details

Applicant: Nexan Telemed , Ltd.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 1999-10-28
Decision date: 1999-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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Adverse events under product code MWJ

product code MWJ

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.