ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS— 510(k) K971053
Substantially EquivalentInternational Medical Products, Inc.
FDA 510(k) clearance K971053 for ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS, Substantially Equivalent on 1997-06-16. Applicant: International Medical Products, Inc..
Clearance details
- Applicant
- International Medical Products, Inc.
- Product code
- Code KPO
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
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.