POLYTECH PULMONARY FUNCTION FILTER— 510(k) K042758

Name: FDA 510(k) clearance K042758
Creator: U.S. Food and Drug Administration
Published: 2005-08-29

Substantially Equivalent

Polytechnic Resources, Inc.

FDA 510(k) clearance K042758 for POLYTECH PULMONARY FUNCTION FILTER, Substantially Equivalent on 2005-08-29. Applicant: Polytechnic Resources, Inc.. Device class: 2.

Clearance details

Applicant: Polytechnic Resources, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2004-10-04
Decision date: 2005-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZG

view all

K251777 — MESI mTABLET SPIRO2026-03-02
K241843 — TD-7301 Spirometer (TD-7301)2024-11-20
K231416 — Air Next (NVD-02)2024-01-18
K230501 — Spirobank Oxi2023-12-15
K230178 — EasyOne Sky Spirometer2023-10-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.