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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
Teleflex Medical, Inc
3015 Carrington Mill Blvd , Suite 600 North
Morrisville,  NC  27560
Applicant Contact Sirisha Kommana
Correspondent
Teleflex Medical, Inc
3015 Carrington Mill Blvd , Suite 600 North
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
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