ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.— 510(k) K897197
Substantially EquivalentAdvance Medical Designs, Inc.
FDA 510(k) clearance K897197 for ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI., Substantially Equivalent on 1990-03-19. Applicant: Advance Medical Designs, Inc..
Clearance details
- Applicant
- Advance Medical Designs, Inc.
- Product code
- Code DTL
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, 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.