MODEL 6100 AMBULATORY INFUSION SYSTEM— 510(k) K943310
Substantially Equivalent - Subject to Tracking Reg.Pharmacia Deltec, Inc.
FDA 510(k) clearance K943310 for MODEL 6100 AMBULATORY INFUSION SYSTEM, Substantially Equivalent - Subject to Tracking Reg. on 1995-02-21. Applicant: Pharmacia Deltec, Inc..
Clearance details
- Applicant
- Pharmacia Deltec, Inc.
- Product code
- Code MEA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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.