DeviceClearance

HANAULUX BLUE 75 AND HANAULUX BLUE 120— 510(k) K973466

Substantially Equivalent

Heraeus Med GmbH

FDA 510(k) clearance K973466 for HANAULUX BLUE 75 AND HANAULUX BLUE 120, Substantially Equivalent on 1997-10-24. Applicant: Heraeus Med GmbH.

Clearance details

Applicant
Heraeus Med GmbH
Product code
Code FSY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hanau, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

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.