NOUVAG AG - VACUSON 40 AND VACUSON 60— 510(k) K042943

Substantially Equivalent

NOUVAG AG

FDA 510(k) clearance K042943 for NOUVAG AG - VACUSON 40 AND VACUSON 60, Substantially Equivalent on 2004-12-17. Applicant: NOUVAG AG. Device class: 2.

Clearance details

Applicant
NOUVAG AG
Product code
Code BTA
Device class
Class 2
Regulation
21 CFR 878.4780
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gebenstorf, CH
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BTA

product code BTA
Death
5
Total
5

Source: openFDA MAUDE database, through . 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.