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)

POLYTECH PULMONARY FUNCTION FILTER

K-Number: K042758 · 2005-08-29

ApplicantPolytechnic Resources, Inc.
Decision Date2005-08-29
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POLYTECH PULMONARY FUNCTION FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Polytechnic Resources, Inc.. It received FDA 510(k) clearance on 2005-08-29 under 510(k) number K042758. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYTECH PULMONARY FUNCTION FILTER?

POLYTECH PULMONARY FUNCTION FILTER is a medical device that received FDA 510(k) clearance on 2005-08-29. The listed applicant is Polytechnic Resources, Inc.. The 510(k) number is K042758.

When did POLYTECH PULMONARY FUNCTION FILTER receive FDA 510(k) clearance?

POLYTECH PULMONARY FUNCTION FILTER received FDA 510(k) clearance on 2005-08-29, under 510(k) number K042758.

Who is the listed applicant for POLYTECH PULMONARY FUNCTION FILTER?

The FDA 510(k) record lists Polytechnic Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYTECH PULMONARY FUNCTION FILTER?

The FDA product code for POLYTECH PULMONARY FUNCTION FILTER is BZG.

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

Related Devices (Code: BZG)

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.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

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.

↑