MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004— 510(k) K992305

Substantially Equivalent

Medi-Stim A/S

FDA 510(k) clearance K992305 for MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004, Substantially Equivalent on 1999-09-08. Applicant: Medi-Stim A/S.

Clearance details

Applicant: Medi-Stim A/S
Product code: Code ITX
Advisory panel: Radiology
Date received: 1999-07-08
Decision date: 1999-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oslo, NO

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.