Phoenix XL Dialysate Meter— 510(k) K150657
Substantially EquivalentMesa Laboratories, Inc.
FDA 510(k) clearance K150657 for Phoenix XL Dialysate Meter, Substantially Equivalent on 2015-09-21. Applicant: Mesa Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Mesa Laboratories, Inc.
- Product code
- Code FIZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
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