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FDA 510(k)

HEMASITE ACCESS MONITOR (TENT.) #RS-8200

K-Number: K811977 · 1981-07-31

ApplicantRenal Systems, Inc.
Decision Date1981-07-31
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMASITE ACCESS MONITOR (TENT.) #RS-8200 is the device name listed in this FDA 510(k) record. The listed applicant is Renal Systems, Inc.. It received FDA 510(k) clearance on 1981-07-31 under 510(k) number K811977. 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 HEMASITE ACCESS MONITOR (TENT.) #RS-8200?

HEMASITE ACCESS MONITOR (TENT.) #RS-8200 is a medical device that received FDA 510(k) clearance on 1981-07-31. The listed applicant is Renal Systems, Inc.. The 510(k) number is K811977.

When did HEMASITE ACCESS MONITOR (TENT.) #RS-8200 receive FDA 510(k) clearance?

HEMASITE ACCESS MONITOR (TENT.) #RS-8200 received FDA 510(k) clearance on 1981-07-31, under 510(k) number K811977.

Who is the listed applicant for HEMASITE ACCESS MONITOR (TENT.) #RS-8200?

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

What is the FDA product code for HEMASITE ACCESS MONITOR (TENT.) #RS-8200?

The FDA product code for HEMASITE ACCESS MONITOR (TENT.) #RS-8200 is KOC.

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Related Devices (Code: 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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