PERFORMER HT/ HANG&GO HT BASIC— 510(k) K120026

Substantially Equivalent

Rand S.R.L.

FDA 510(k) clearance K120026 for PERFORMER HT/ HANG&GO HT BASIC, Substantially Equivalent on 2012-05-08. Applicant: Rand S.R.L..

Clearance details

Applicant: Rand S.R.L.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2012-01-03
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medolla, (Mo), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.