Suitcase Kidney Hemodialysis System
FDA 510(k) K781405 · Union Carbide Corp.
510(k) numberK781405
Submission
- Device name
- Suitcase Kidney Hemodialysis System
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- August 14, 1978
- Decision date
- December 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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Questions and answers
When was Suitcase Kidney Hemodialysis System cleared by the FDA?
Suitcase Kidney Hemodialysis System (K781405) received a 510(k) decision of Substantially Equivalent on December 7, 1978, 115 days after the submission was received.
What is the product code of K781405?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.