HEMODIALYSIS SYSTEM
FDA 510(k) clearance K813432 · decided 1982-06-23
Clearance details
- K-number
- K813432
- Device name
- HEMODIALYSIS SYSTEM
- Applicant
- Fhk
- Decision
- Substantially Equivalent
- Date received
- 1981-12-08
- Decision date
- 1982-06-23
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- FKP
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.