FDA.report

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

Related Records

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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