SAFE MATE I.V. FLUID DELIVERY SETS— 510(k) K962802
Substantially EquivalentBiological & Environmental Control Laboratories
FDA 510(k) clearance K962802 for SAFE MATE I.V. FLUID DELIVERY SETS, Substantially Equivalent on 1996-08-28. Applicant: Biological & Environmental Control Laboratories.
Clearance details
- Applicant
- Biological & Environmental Control Laboratories
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toledo, OH, US
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.