FDA.reportPublic FDA data

510(k) K233441

Device
The Vest APX System (PVAPX1)
Applicant
Baxter Healthcare Corportation
510(k) number
K233441
Product code
BYI
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-22
Date received
2023-10-18
Regulation
868.5665
Classification name
Percussor, Powered-Electric
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Steven Co
Address
One Baxter Pkwy. Deerfield Lake IL US 60015 60015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K163378Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd.2017-03-17
K142482The Vest Airway Clearance SystemHill-Rom Services Private Limited2015-05-07
K132794SMARTVEST AIRWAY CLEARANCE SYSTEMElectromed, Inc.2013-12-19
K121587BREATH SHAKECheen Houng Ent. Co. , Ltd.2013-11-22
K122480INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVESTInternational Biophysics Corporation2013-03-27
K121170RESIN 11Respinnovation Sas2012-07-13
K103176FREQUENCERDymedso, Inc.2011-01-26