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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K182847
Device Name Hudson RCI Voldyne Volumetric Exerciser
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Suite 600n
Morrisville,  NC  27560
Applicant Contact Sirisha Kommana
Correspondent
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Suite 600n
Morrisville,  NC  27560
Correspondent Contact Sirisha Kommana
Regulation Number868.5690
Classification Product Code
BWF  
Date Received10/09/2018
Decision Date 07/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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