PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)— 510(k) K023616

Substantially Equivalent

Ivy Biomedical Systems, Inc.

FDA 510(k) clearance K023616 for PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES), Substantially Equivalent on 2002-11-04. Applicant: Ivy Biomedical Systems, Inc..

Clearance details

Applicant: Ivy Biomedical Systems, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2002-10-29
Decision date: 2002-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Branford, CT, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.