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FDA 510(k)

ACCUFLO 100

K-Number: K810074 · 1981-03-04

Decision Date1981-03-04
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACCUFLO 100 is the device name listed in this FDA 510(k) record. The listed applicant is Renal Care Corp.. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810074. 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 ACCUFLO 100?

ACCUFLO 100 is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Renal Care Corp.. The 510(k) number is K810074.

When did ACCUFLO 100 receive FDA 510(k) clearance?

ACCUFLO 100 received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810074.

Who is the listed applicant for ACCUFLO 100?

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

What is the FDA product code for ACCUFLO 100?

The FDA product code for ACCUFLO 100 is KOC.

Related Clinical Trials

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.

Other records listing Renal Care 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.

Related Devices (Code: KOC)

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.

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.

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