MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT— 510(k) K133807
Substantially EquivalentGambro Renal Products, Inc.
FDA 510(k) clearance K133807 for MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT, Substantially Equivalent on 2014-03-26. Applicant: Gambro Renal Products, Inc..
Clearance details
- Applicant
- Gambro Renal Products, Inc.
- Product code
- Code FLD
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.