LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE— 510(k) K870722
Substantially EquivalentNational Medical Care, Medical Products Div., Inc.
FDA 510(k) clearance K870722 for LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE, Substantially Equivalent on 1988-09-14. Applicant: National Medical Care, Medical Products Div., Inc..
Clearance details
- Applicant
- National Medical Care, Medical Products Div., Inc.
- Product code
- Code FJK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockleigh, NJ, US
Adverse events under product code FJK
product code FJK- Death
- 52
- Malfunction
- 3,430
- Total
- 3,482
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.