4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG— 510(k) K973364
Substantially EquivalentMaersk Medical A/S
FDA 510(k) clearance K973364 for 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG, Substantially Equivalent on 1998-03-17. Applicant: Maersk Medical A/S. Device class: 2.
Clearance details
- Applicant
- Maersk Medical A/S
- Product code
- Code KNX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harlev, DK
Recent devices under product code KNX
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- K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
Adverse events under product code KNX
product code KNX- Malfunction
- 1,064
- Total
- 1,064
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.