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FDA 510(k)

NEPHROSS PRESTO

K-Number: K832666 · 1983-10-14

ApplicantOrganon Teknika Corp.
Decision Date1983-10-14
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEPHROSS PRESTO is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832666. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPHROSS PRESTO?

NEPHROSS PRESTO is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Organon Teknika Corp.. The 510(k) number is K832666.

When did NEPHROSS PRESTO receive FDA 510(k) clearance?

NEPHROSS PRESTO received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832666.

Who is the listed applicant for NEPHROSS PRESTO?

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

What is the FDA product code for NEPHROSS PRESTO?

The FDA product code for NEPHROSS PRESTO is KOC.

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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.

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