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FDA 510(k)

ARGOMEDICAL BIPOLAR SYSTEM

K-Number: K981451 · 1998-08-21

ApplicantStelkast Company
Decision Date1998-08-21
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARGOMEDICAL BIPOLAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K981451. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGOMEDICAL BIPOLAR SYSTEM?

ARGOMEDICAL BIPOLAR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Stelkast Company. The 510(k) number is K981451.

When did ARGOMEDICAL BIPOLAR SYSTEM receive FDA 510(k) clearance?

ARGOMEDICAL BIPOLAR SYSTEM received FDA 510(k) clearance on 1998-08-21, under 510(k) number K981451.

Who is the listed applicant for ARGOMEDICAL BIPOLAR SYSTEM?

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

What is the FDA product code for ARGOMEDICAL BIPOLAR SYSTEM?

The FDA product code for ARGOMEDICAL BIPOLAR SYSTEM is KWL.

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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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