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FDA 510(k)

MODEL RS-8100

K-Number: K811457 · 1981-06-23

ApplicantRinal Systems, Inc.
Decision Date1981-06-23
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL RS-8100 is the device name listed in this FDA 510(k) record. The listed applicant is Rinal Systems, Inc.. It received FDA 510(k) clearance on 1981-06-23 under 510(k) number K811457. 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 MODEL RS-8100?

MODEL RS-8100 is a medical device that received FDA 510(k) clearance on 1981-06-23. The listed applicant is Rinal Systems, Inc.. The 510(k) number is K811457.

When did MODEL RS-8100 receive FDA 510(k) clearance?

MODEL RS-8100 received FDA 510(k) clearance on 1981-06-23, under 510(k) number K811457.

Who is the listed applicant for MODEL RS-8100?

The FDA 510(k) record lists Rinal Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL RS-8100?

The FDA product code for MODEL RS-8100 is KOC.

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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.

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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.

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