Peritoneal Dialysis System
FDA 510(k) K760724 · Physio-Control Corp.
510(k) numberK760724
Submission
- Device name
- Peritoneal Dialysis System
- Applicant
- Physio-Control Corp.
Mchenry, IL, US - Received
- September 27, 1976
- Decision date
- November 23, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Peritoneal Dialysis System cleared by the FDA?
Peritoneal Dialysis System (K760724) received a 510(k) decision of Substantially Equivalent on November 23, 1976, 57 days after the submission was received.
What is the product code of K760724?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.