PERFORMER CBP SYSTEM— 510(k) K070213

Name: FDA 510(k) clearance K070213
Creator: U.S. Food and Drug Administration
Published: 2007-03-21

Substantially Equivalent

Rand S.R.L.

FDA 510(k) clearance K070213 for PERFORMER CBP SYSTEM, Substantially Equivalent on 2007-03-21. Applicant: Rand S.R.L.. Device class: 2.

Clearance details

Applicant: Rand S.R.L.
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 2007-01-22
Decision date: 2007-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.