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FDA 510(k)

INIVOX ELECTRODE/CATHETER SYS

K-Number: K832916 · 1983-11-14

ApplicantCritikon Company, LLC
Decision Date1983-11-14
Product CodeLLE
DecisionSubstantially Equivalent

Device Summary

INIVOX ELECTRODE/CATHETER SYS is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832916. The device is classified under product code LLE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INIVOX ELECTRODE/CATHETER SYS?

INIVOX ELECTRODE/CATHETER SYS is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Critikon Company, LLC. The 510(k) number is K832916.

When did INIVOX ELECTRODE/CATHETER SYS receive FDA 510(k) clearance?

INIVOX ELECTRODE/CATHETER SYS received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832916.

Who is the listed applicant for INIVOX ELECTRODE/CATHETER SYS?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INIVOX ELECTRODE/CATHETER SYS?

The FDA product code for INIVOX ELECTRODE/CATHETER SYS is LLE.

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Other records listing Critikon Company, LLC as applicant

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Related Devices (Code: LLE)

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.

K833430BLOOD GAS EXPERSYSTEM 8700Medical Intelcom, Inc.

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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