DRAGER SOLA SERIES, MODELS 1000/700/500/300— 510(k) K984611

Substantially Equivalent

Drager Medizintechnik GmbH

FDA 510(k) clearance K984611 for DRAGER SOLA SERIES, MODELS 1000/700/500/300, Substantially Equivalent on 1999-03-29. Applicant: Drager Medizintechnik GmbH.

Clearance details

Applicant: Drager Medizintechnik GmbH
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 1998-12-29
Decision date: 1999-03-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lubeck, DE

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Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.