FDA 510(k)

G.E. POLARIX II C-ARM

K-Number: K902982 · 1990-11-13

ApplicantElectromek Diagnostic Systems, Inc.

Decision Date1990-11-13

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

G.E. POLARIX II C-ARM is the device name listed in this FDA 510(k) record. The listed applicant is Electromek Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K902982. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G.E. POLARIX II C-ARM?

G.E. POLARIX II C-ARM is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is Electromek Diagnostic Systems, Inc.. The 510(k) number is K902982.

When did G.E. POLARIX II C-ARM receive FDA 510(k) clearance?

G.E. POLARIX II C-ARM received FDA 510(k) clearance on 1990-11-13, under 510(k) number K902982.

Who is the listed applicant for G.E. POLARIX II C-ARM?

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

What is the FDA product code for G.E. POLARIX II C-ARM?

The FDA product code for G.E. POLARIX II C-ARM is JAA.

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Other records listing Electromek Diagnostic Systems, 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.