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FDA 510(k)

COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR

K-Number: K023733 · 2003-05-14

ApplicantIngenjorsfirman Bjorn Bergdahl AB
Decision Date2003-05-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ingenjorsfirman Bjorn Bergdahl AB. It received FDA 510(k) clearance on 2003-05-14 under 510(k) number K023733. 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 COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR?

COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR is a medical device that received FDA 510(k) clearance on 2003-05-14. The listed applicant is Ingenjorsfirman Bjorn Bergdahl AB. The 510(k) number is K023733.

When did COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR receive FDA 510(k) clearance?

COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR received FDA 510(k) clearance on 2003-05-14, under 510(k) number K023733.

Who is the listed applicant for COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR?

The FDA 510(k) record lists Ingenjorsfirman Bjorn Bergdahl AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR?

The FDA product code for COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR 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.

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