Alveoair Digital Spirometer
FDA 510(k) K222525 · Roundworks Technologies Private Limited
510(k) numberK222525
Submission
- Device name
- Alveoair Digital Spirometer
- Applicant
- Roundworks Technologies Private Limited
Wakad, Pune, IN - Received
- August 22, 2022
- Decision date
- August 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
Other 510(k)s with product code BZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251777 | MESI mTABLET SPIROBZG · Traditional | Mesi D.O.O. | 03/02/2026SE |
| K241843 | TD-7301 Spirometer (TD-7301)BZG · Traditional | Gostar Co., Ltd. | 11/20/2024SE |
| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
| K230501 | Spirobank OxiBZG · Traditional | Mir Medical International Research USA | 12/15/2023SE |
| K230178 | EasyOne Sky SpirometerBZG · Traditional | Ndd Medizintechnik AG | 10/19/2023SE |
| K222443 | Air Smart Extra SpirometerBZG · Traditional | Feellife Health, Inc. | 08/09/2023SE |
| K213754 | SpiroHome Personal, SpiroHome ClinicBZG · Traditional | Inofab Saglik Teknolojileri A.S | 06/12/2023SE |
| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
| K201493 | SpirometerBZG · Traditional | Mehow Innovative, Ltd. | 06/10/2021SE |
Questions and answers
When was Alveoair Digital Spirometer cleared by the FDA?
Alveoair Digital Spirometer (K222525) received a 510(k) decision of Substantially Equivalent on August 28, 2023, 371 days after the submission was received.
What is the product code of K222525?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.