PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R— 510(k) K071909
Substantially EquivalentBarkey GmbH & Co. KG
FDA 510(k) clearance K071909 for PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R, Substantially Equivalent on 2007-10-18. Applicant: Barkey GmbH & Co. KG.
Clearance details
- Applicant
- Barkey GmbH & Co. KG
- Product code
- Code KOC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Leopoldshoehe, DE
Adverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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.