BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR— 510(k) K864179
Substantially EquivalentAsh Medical Systems, Inc.
FDA 510(k) clearance K864179 for BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR, Substantially Equivalent on 1986-12-11. Applicant: Ash Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ash Medical Systems, Inc.
- Product code
- Code FKT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5600
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Lafayette, IN, US
Recent devices under product code FKT
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