HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS— 510(k) K842829
Substantially EquivalentNorth American Instrument Corp.
FDA 510(k) clearance K842829 for HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS, Substantially Equivalent on 1984-10-18. Applicant: North American Instrument Corp..
Clearance details
- Applicant
- North American Instrument Corp.
- Product code
- Code DTL
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hudson Falls, NY, US
Adverse events under product code DTL
product code DTL- Malfunction
- 770
- Total
- 770
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.