TRACER— 510(k) K881842

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K881842 for TRACER, Substantially Equivalent on 1988-08-31. Applicant: Life-Tech Intl., Inc..

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 1988-05-02
Decision date: 1988-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code BXN

product code BXN

Other: 1
Total: 1

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.