BZG — Spirometer, Diagnostic Class II

FDA Device Classification

Classification Details

Product Code
BZG
Device Class
Class II
Regulation Number
868.1840
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251777mesiMESI mTABLET SPIROMarch 2, 2026
K241843gostar coTD-7301 Spirometer (TD-7301)November 20, 2024
K231416nuvoairAir Next (NVD-02)January 18, 2024
K230501mir medical international research usaSpirobank OxiDecember 15, 2023
K230178ndd medizintechnikEasyOne Sky SpirometerOctober 19, 2023
K222525roundworks technologies private limitedAlveoair Digital SpirometerAugust 28, 2023
K222443feellife healthAir Smart Extra SpirometerAugust 9, 2023
K213754inofab saglik teknolojileri a.sSpiroHome Personal, SpiroHome ClinicJune 12, 2023
K213872morgan scientificComPAS2July 15, 2022
K212938vitalograph irelandVitalograph Model 6000 AlphaJanuary 26, 2022
K201493mehow innovativeSpirometerJune 10, 2021
K202837monitored therapeuticsGoSpiroDecember 4, 2020
K201562vitalograph irelandSpirotracOctober 14, 2020
K201002safey medical devices pvtSafey Pocket SpirometerJuly 30, 2020
K200550vitalograph irelandVitalograph Model 2120 In2itive eDiaryJuly 27, 2020
K183089nuvoairAir NextJanuary 2, 2020
K183479eresearch technologyAsthma Monitor AM3October 3, 2019
K191013welch allynWelch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionSeptember 10, 2019
K190568morgan scientificComPAS2 (Computerized Pulmonary Analysis System)June 6, 2019
K180011pulmonx corporationPulmonx Chartis Tablet ConsoleJuly 13, 2018