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FDA 510(k)

CRI ELECTRONIC CONTROL SYSTEM

K-Number: K924125 · 1993-05-26

ApplicantCatheter Research C/O Burditt, Bowles & Radzius
Decision Date1993-05-26
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRI ELECTRONIC CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K924125. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRI ELECTRONIC CONTROL SYSTEM?

CRI ELECTRONIC CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. The 510(k) number is K924125.

When did CRI ELECTRONIC CONTROL SYSTEM receive FDA 510(k) clearance?

CRI ELECTRONIC CONTROL SYSTEM received FDA 510(k) clearance on 1993-05-26, under 510(k) number K924125.

Who is the listed applicant for CRI ELECTRONIC CONTROL SYSTEM?

The FDA 510(k) record lists Catheter Research C/O Burditt, Bowles & Radzius as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRI ELECTRONIC CONTROL SYSTEM?

The FDA product code for CRI ELECTRONIC CONTROL SYSTEM is DXX.

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Other records listing Catheter Research C/O Burditt, Bowles & Radzius 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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Related Devices (Code: DXX)

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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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