FDA 510(k)

STERLING MEDICAL IMPULSE 3 STIMULATOR

K-Number: K121305 · 2012-09-25

ApplicantArmstrong Industries, Inc. Dha Mediquip Int. Dha S

Decision Date2012-09-25

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STERLING MEDICAL IMPULSE 3 STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Armstrong Industries, Inc. Dha Mediquip Int. Dha S. It received FDA 510(k) clearance on 2012-09-25 under 510(k) number K121305. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERLING MEDICAL IMPULSE 3 STIMULATOR?

STERLING MEDICAL IMPULSE 3 STIMULATOR is a medical device that received FDA 510(k) clearance on 2012-09-25. The listed applicant is Armstrong Industries, Inc. Dha Mediquip Int. Dha S. The 510(k) number is K121305.

When did STERLING MEDICAL IMPULSE 3 STIMULATOR receive FDA 510(k) clearance?

STERLING MEDICAL IMPULSE 3 STIMULATOR received FDA 510(k) clearance on 2012-09-25, under 510(k) number K121305.

Who is the listed applicant for STERLING MEDICAL IMPULSE 3 STIMULATOR?

The FDA 510(k) record lists Armstrong Industries, Inc. Dha Mediquip Int. Dha S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERLING MEDICAL IMPULSE 3 STIMULATOR?

The FDA product code for STERLING MEDICAL IMPULSE 3 STIMULATOR is GZJ.

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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.