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FDA 510(k)

NEPHROSS, ANDANTE H.F.

K-Number: K823375 · 1982-12-07

ApplicantOrganon Teknika Corp.
Decision Date1982-12-07
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEPHROSS, ANDANTE H.F. 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 1982-12-07 under 510(k) number K823375. 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, ANDANTE H.F.?

NEPHROSS, ANDANTE H.F. is a medical device that received FDA 510(k) clearance on 1982-12-07. The listed applicant is Organon Teknika Corp.. The 510(k) number is K823375.

When did NEPHROSS, ANDANTE H.F. receive FDA 510(k) clearance?

NEPHROSS, ANDANTE H.F. received FDA 510(k) clearance on 1982-12-07, under 510(k) number K823375.

Who is the listed applicant for NEPHROSS, ANDANTE H.F.?

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, ANDANTE H.F.?

The FDA product code for NEPHROSS, ANDANTE H.F. 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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