DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100— 510(k) K040605

Name: FDA 510(k) clearance K040605
Creator: U.S. Food and Drug Administration
Published: 2004-04-26

Substantially Equivalent

Dymedix, Inc.

FDA 510(k) clearance K040605 for DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100, Substantially Equivalent on 2004-04-26. Applicant: Dymedix, Inc.. Device class: 2.

Clearance details

Applicant: Dymedix, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2004-03-08
Decision date: 2004-04-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

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