EASY ON-PC SPIROMETER— 510(k) K090034

Substantially Equivalent

Ndd Medizitechnik AG

FDA 510(k) clearance K090034 for EASY ON-PC SPIROMETER, Substantially Equivalent on 2009-06-02. Applicant: Ndd Medizitechnik AG. Device class: 2.

Clearance details

Applicant: Ndd Medizitechnik AG
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2009-01-06
Decision date: 2009-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZG

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

More clearances from Ndd Medizitechnik AG

K120635 — EASYONE PRO RESPIRATORY TESTING DEVICE2012-09-27
K091428 — EASYONE PRO RESPIRATORY ANALYSIS SYSTEM2010-01-27

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