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FDA 510(k)

TECHMEDICA STANDARD BIPOLAR SYSTEM

K-Number: K925420 · 1993-09-28

ApplicantTechmedica, Inc.
Decision Date1993-09-28
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TECHMEDICA STANDARD BIPOLAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Techmedica, Inc.. It received FDA 510(k) clearance on 1993-09-28 under 510(k) number K925420. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHMEDICA STANDARD BIPOLAR SYSTEM?

TECHMEDICA STANDARD BIPOLAR SYSTEM is a medical device that received FDA 510(k) clearance on 1993-09-28. The listed applicant is Techmedica, Inc.. The 510(k) number is K925420.

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

TECHMEDICA STANDARD BIPOLAR SYSTEM received FDA 510(k) clearance on 1993-09-28, under 510(k) number K925420.

Who is the listed applicant for TECHMEDICA STANDARD BIPOLAR SYSTEM?

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

What is the FDA product code for TECHMEDICA STANDARD BIPOLAR SYSTEM?

The FDA product code for TECHMEDICA STANDARD BIPOLAR SYSTEM is KWY.

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Other records listing Techmedica, Inc. as applicant

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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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