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FDA 510(k)

AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR

K-Number: K040580 · 2004-08-26

ApplicantD.Y. Instrument, Inc.
Decision Date2004-08-26
Product CodeNRW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is D.Y. Instrument, Inc.. It received FDA 510(k) clearance on 2004-08-26 under 510(k) number K040580. The device is classified under product code NRW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR?

AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR is a medical device that received FDA 510(k) clearance on 2004-08-26. The listed applicant is D.Y. Instrument, Inc.. The 510(k) number is K040580.

When did AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR receive FDA 510(k) clearance?

AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR received FDA 510(k) clearance on 2004-08-26, under 510(k) number K040580.

Who is the listed applicant for AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR?

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

What is the FDA product code for AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR?

The FDA product code for AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR is NRW.

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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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