FDA 510(k)

CARDIOVATIONS OPTICAL BIPOLAR DEVICE

K-Number: K031846 · 2003-07-21

Decision Date2003-07-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CARDIOVATIONS OPTICAL BIPOLAR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2003-07-21 under 510(k) number K031846. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVATIONS OPTICAL BIPOLAR DEVICE?

CARDIOVATIONS OPTICAL BIPOLAR DEVICE is a medical device that received FDA 510(k) clearance on 2003-07-21. The listed applicant is ETHICON, Inc.. The 510(k) number is K031846.

When did CARDIOVATIONS OPTICAL BIPOLAR DEVICE receive FDA 510(k) clearance?

CARDIOVATIONS OPTICAL BIPOLAR DEVICE received FDA 510(k) clearance on 2003-07-21, under 510(k) number K031846.

Who is the listed applicant for CARDIOVATIONS OPTICAL BIPOLAR DEVICE?

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

What is the FDA product code for CARDIOVATIONS OPTICAL BIPOLAR DEVICE?

The FDA product code for CARDIOVATIONS OPTICAL BIPOLAR DEVICE is GEI.

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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.