VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)— 510(k) K010732

Substantially Equivalent

Telemedic Systems, Inc.

FDA 510(k) clearance K010732 for VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM), Substantially Equivalent on 2001-09-27. Applicant: Telemedic Systems, Inc..

Clearance details

Applicant: Telemedic Systems, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2001-03-12
Decision date: 2001-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.