NEOMED SINGLE LUMEN UMBILICAL CATHETER— 510(k) K073596
Substantially EquivalentNeomed, Inc.
FDA 510(k) clearance K073596 for NEOMED SINGLE LUMEN UMBILICAL CATHETER, Substantially Equivalent on 2008-02-22. Applicant: Neomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Neomed, Inc.
- Product code
- Code FOS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Swanee, GA, US
Recent devices under product code FOS
view allMore clearances from Neomed, Inc.
view all- K183540 — Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
- K161039 — NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
- K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
- K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector
- K122373 — NEOMED ORAL/ENTERAL SYRINGE
Adverse events under product code FOS
product code FOS- Death
- 12
- Other
- 1
- Total
- 13
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.