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FDA 510(k)

LO-COMP RESERVOIR-RE-1000

K-Number: K831163 · 1983-05-03

Decision Date1983-05-03
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LO-COMP RESERVOIR-RE-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Cygnus Research Corp.. It received FDA 510(k) clearance on 1983-05-03 under 510(k) number K831163. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LO-COMP RESERVOIR-RE-1000?

LO-COMP RESERVOIR-RE-1000 is a medical device that received FDA 510(k) clearance on 1983-05-03. The listed applicant is Cygnus Research Corp.. The 510(k) number is K831163.

When did LO-COMP RESERVOIR-RE-1000 receive FDA 510(k) clearance?

LO-COMP RESERVOIR-RE-1000 received FDA 510(k) clearance on 1983-05-03, under 510(k) number K831163.

Who is the listed applicant for LO-COMP RESERVOIR-RE-1000?

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

What is the FDA product code for LO-COMP RESERVOIR-RE-1000?

The FDA product code for LO-COMP RESERVOIR-RE-1000 is BTT.

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 Cygnus Research 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: BTT)

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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