OMNI-TRAK PATIENT MONITORING SYSTEM— 510(k) K955045

Substantially Equivalent

Invivo Research, Inc.

FDA 510(k) clearance K955045 for OMNI-TRAK PATIENT MONITORING SYSTEM, Substantially Equivalent on 1996-07-11. Applicant: Invivo Research, Inc..

Clearance details

Applicant: Invivo Research, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1995-11-03
Decision date: 1996-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.