MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR— 510(k) K874137
Substantially EquivalentAsh Medical Systems, Inc.
FDA 510(k) clearance K874137 for MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR, Substantially Equivalent on 1988-04-08. 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
view allMore clearances from Ash Medical Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.