Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

The Vest APX System (PVAPX1)

K-Number: K233441 · 2024-03-22

ApplicantBaxter Healthcare Corportation
Decision Date2024-03-22
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

The Vest APX System (PVAPX1) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K233441. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Vest APX System (PVAPX1)?

The Vest APX System (PVAPX1) is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Baxter Healthcare Corportation. The 510(k) number is K233441.

When did The Vest APX System (PVAPX1) receive FDA 510(k) clearance?

The Vest APX System (PVAPX1) received FDA 510(k) clearance on 2024-03-22, under 510(k) number K233441.

Who is the listed applicant for The Vest APX System (PVAPX1)?

The FDA 510(k) record lists Baxter Healthcare Corportation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Vest APX System (PVAPX1)?

The FDA product code for The Vest APX System (PVAPX1) is BYI.

Other records listing Baxter Healthcare Corportation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryK193137EASYGRIP FLO-41 Precision MIS Delivery System

Related Devices (Code: BYI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑