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FDA 510(k)

PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT

K-Number: K854084 · 1985-11-08

ApplicantOrganon Teknika Corp.
Decision Date1985-11-08
Product CodeFKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT 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 1985-11-08 under 510(k) number K854084. The device is classified under product code FKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT?

PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT is a medical device that received FDA 510(k) clearance on 1985-11-08. The listed applicant is Organon Teknika Corp.. The 510(k) number is K854084.

When did PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT receive FDA 510(k) clearance?

PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT received FDA 510(k) clearance on 1985-11-08, under 510(k) number K854084.

Who is the listed applicant for PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT?

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 PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT?

The FDA product code for PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT is FKL.

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Other records listing Organon Teknika Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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