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)

AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER

K-Number: K052332 · 2005-09-21

ApplicantTrudell Medical Intl.
Decision Date2005-09-21
Product CodeNVP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical Intl.. It received FDA 510(k) clearance on 2005-09-21 under 510(k) number K052332. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER?

AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Trudell Medical Intl.. The 510(k) number is K052332.

When did AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER receive FDA 510(k) clearance?

AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER received FDA 510(k) clearance on 2005-09-21, under 510(k) number K052332.

Who is the listed applicant for AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER?

The FDA 510(k) record lists Trudell Medical Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER?

The FDA product code for AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER is NVP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Trudell Medical Intl. 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.

K131881OMBRA TABLE TOP COMPRESSORK123400AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICEK123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)K112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)K110136RESPICHAMBER VALVED HOLDING CHAMBERK090065AEROCHAMBER MINI VENTILATION CHAMBER

View all 12 devices →

Related Devices (Code: NVP)

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.

K242667AeroChamber2go Anti-Static Valved Holding ChamberTrudell Medical InternationalK210558LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberThayer Medical CorporationK181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)Trudell Medical InternationalK160109Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberThayer Medical CorporationK143615Antistatic Compact Space ChamberMedical Developments International LimitedK122252SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUSMedical Developments International

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.

↑