FDA · official record K760724Substantially Equivalent

PERITONEAL DIALYSIS SYSTEM

Name: PERITONEAL DIALYSIS SYSTEM — FDA K760724
Creator: Physio-Control Corp.
Keywords: PERITONEAL DIALYSIS SYSTEM, PERITONEAL DIALYSIS SYSTEM, K760724, EKX, FDA

United StatesEKXPhysio-Control Corp.

Verified

Official record identity

FDA application number: K760724
Decision date: November 23, 1976
Published decision: Substantially Equivalent

Classification

Product code: EKX

Published parties

Applicant: Physio-Control Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1976-09-27
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.