MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR
FDA 510(k) clearance K874137 · decided 1988-04-08
Clearance details
- K-number
- K874137
- Device name
- MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR
- Applicant
- Ash Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-13
- Decision date
- 1988-04-08
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- FKT
- Device class
- 2
- Regulation number
- 876.5600
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- West Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.