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FDA 510(k)

SMD ELECTRODES

K-Number: K943009 · 1995-02-21

ApplicantScientific Medical Devices, Inc.
Decision Date1995-02-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMD ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Medical Devices, Inc.. It received FDA 510(k) clearance on 1995-02-21 under 510(k) number K943009. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMD ELECTRODES?

SMD ELECTRODES is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Scientific Medical Devices, Inc.. The 510(k) number is K943009.

When did SMD ELECTRODES receive FDA 510(k) clearance?

SMD ELECTRODES received FDA 510(k) clearance on 1995-02-21, under 510(k) number K943009.

Who is the listed applicant for SMD ELECTRODES?

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

What is the FDA product code for SMD ELECTRODES?

The FDA product code for SMD ELECTRODES is GXY.

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Official Source

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