BZG · Spirometer, Diagnostic
Anesthesiology · 21 CFR 868.1840 · Class 2
Overview
| Product Code | BZG |
|---|---|
| Device Name | Spirometer, Diagnostic |
| Regulation | 21 CFR 868.1840 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 228)
Showing 20 most recent of 228 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | Mar 2, 2026 | SESE |
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | Nov 20, 2024 | SESE |
| K231416 | Air Next (NVD-02) | Nuvoair AB | Jan 18, 2024 | SESE |
| K230501 | Spirobank Oxi | Mir Medical International Research USA | Dec 15, 2023 | SESE |
| K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | Oct 19, 2023 | SESE |
| K222525 | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | Aug 28, 2023 | SESE |
| K222443 | Air Smart Extra Spirometer | Feellife Health, Inc. | Aug 9, 2023 | SESE |
| K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | Jun 12, 2023 | SESE |
| K213872 | ComPAS2 | Morgan Scientific, Inc. | Jul 15, 2022 | SESE |
| K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | Jan 26, 2022 | SESE |
| K201493 | Spirometer | Mehow Innovative, Ltd. | Jun 10, 2021 | SESE |
| K202837 | GoSpiro | Monitored Therapeutics, Inc. | Dec 4, 2020 | SESE |
| K201562 | Spirotrac | Vitalograph Ireland, Ltd. | Oct 14, 2020 | SESE |
| K201002 | Safey Pocket Spirometer | Safey Medical Devices Pvt, Ltd. | Jul 30, 2020 | SESE |
| K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | Jul 27, 2020 | SESE |
| K183089 | Air Next | Nuvoair AB | Jan 2, 2020 | SESE |
| K183479 | Asthma Monitor AM3 | Eresearch Technology | Oct 3, 2019 | SESE |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Welch Allyn, Inc. | Sep 10, 2019 | SESE |
| K190568 | ComPAS2 (Computerized Pulmonary Analysis System) | Morgan Scientific, Inc. | Jun 6, 2019 | SESE |
| K180011 | Pulmonx Chartis Tablet Console | Pulmonx Corporation | Jul 13, 2018 | SESE |
Top Applicants
- Mir Medical Intl. Research Srl — 9 clearances
- Sdi Diagnostics, Inc. — 8 clearances
- Vitalograph (Ireland) , Ltd. — 6 clearances
- Future Impex Corp. — 5 clearances
- Medical Equipment Designs, Inc. — 5 clearances
