MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis— 510(k) K153329
Substantially EquivalentMed-Tech Water Systems, Inc.
FDA 510(k) clearance K153329 for MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis, Substantially Equivalent on 2016-08-04. Applicant: Med-Tech Water Systems, Inc..
Clearance details
- Applicant
- Med-Tech Water Systems, Inc.
- Product code
- Code FIP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, CA, US
Adverse events under product code FIP
product code FIP- Malfunction
- 490
- Total
- 490
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.