AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR— 510(k) K040580

Name: FDA 510(k) clearance K040580
Creator: U.S. Food and Drug Administration
Published: 2004-08-26

Substantially Equivalent

D.Y. Instrument, Inc.

FDA 510(k) clearance K040580 for AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR, Substantially Equivalent on 2004-08-26. Applicant: D.Y. Instrument, Inc.. Device class: 2.

Clearance details

Applicant: D.Y. Instrument, Inc.
Product code: Code NRW
Device class: Class 2
Regulation: 21 CFR 880.5580
Advisory panel: General Hospital
Date received: 2004-03-04
Decision date: 2004-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cherry Hill, NJ, US

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