510(k) K983274— STARTRACK INFANT GRAPHICS MONITOR

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1998-09-17
Decision date: 1998-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.