FDA 510(k)

PERITONEAL DIALYSIS CYCLER SET W/PUMP

K-Number: K801220 · 1980-08-12

ApplicantAmerican Medical Products, Inc.

Decision Date1980-08-12

Product CodeKDJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PERITONEAL DIALYSIS CYCLER SET W/PUMP is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Products, Inc.. It received FDA 510(k) clearance on 1980-08-12 under 510(k) number K801220. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERITONEAL DIALYSIS CYCLER SET W/PUMP?

PERITONEAL DIALYSIS CYCLER SET W/PUMP is a medical device that received FDA 510(k) clearance on 1980-08-12. The listed applicant is American Medical Products, Inc.. The 510(k) number is K801220.

When did PERITONEAL DIALYSIS CYCLER SET W/PUMP receive FDA 510(k) clearance?

PERITONEAL DIALYSIS CYCLER SET W/PUMP received FDA 510(k) clearance on 1980-08-12, under 510(k) number K801220.

Who is the listed applicant for PERITONEAL DIALYSIS CYCLER SET W/PUMP?

The FDA 510(k) record lists American Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERITONEAL DIALYSIS CYCLER SET W/PUMP?

The FDA product code for PERITONEAL DIALYSIS CYCLER SET W/PUMP is KDJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.