VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600— 510(k) K934482

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K934482 for VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600, Substantially Equivalent on 1994-05-02. Applicant: Vital Signs, Inc..

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1993-09-14
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, NJ, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.