TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE— 510(k) K011571

Substantially Equivalent

The RX Files Corp.

FDA 510(k) clearance K011571 for TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE, Substantially Equivalent on 2001-08-09. Applicant: The RX Files Corp..

Clearance details

Applicant: The RX Files Corp.
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 2001-05-21
Decision date: 2001-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

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.