FDA 510(k)

DIALYSIS SYS., PDS 400 & RO 400

K-Number: K781156 · 1978-10-24

Decision Date1978-10-24

Product CodeDJC

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

DIALYSIS SYS., PDS 400 & RO 400 is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781156. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYSIS SYS., PDS 400 & RO 400?

DIALYSIS SYS., PDS 400 & RO 400 is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Physio-Control Corp.. The 510(k) number is K781156.

When did DIALYSIS SYS., PDS 400 & RO 400 receive FDA 510(k) clearance?

DIALYSIS SYS., PDS 400 & RO 400 received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781156.

Who is the listed applicant for DIALYSIS SYS., PDS 400 & RO 400?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIALYSIS SYS., PDS 400 & RO 400?

The FDA product code for DIALYSIS SYS., PDS 400 & RO 400 is DJC.

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Official Source

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