Spirotel
FDA 510(k) K043528 · Mir Medical Intl. Research Srl
510(k) numberK043528
Submission
- Device name
- Spirotel
- Applicant
- Mir Medical Intl. Research Srl
Roma, IT - Received
- December 21, 2004
- Decision date
- July 19, 2005
- 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 |
| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
| 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 |
More from Vitalograph Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K130784 | SpirotelBZG · Special | 10/30/2013SE |
| K122384 | MinispirBZG · Special | 10/04/2012SE |
| K081033 | MiroxiDQA · Traditional | 01/15/2009SE |
| K082766 | Modification to Minispir, Spirolab IIIBZG · Special | 12/17/2008SE |
| K072979 | Spirobank GBZG · Special | 12/26/2007SE |
| K061875 | Minispir; Spirolab IIIBZG · Traditional | 12/11/2006SE |
| K061712 | Spirobank IIBZG · Traditional | 12/01/2006SE |
| K052140 | Spirolab, Spirolab IIBZG · Traditional | 03/16/2006SE |
| K983909 | Mir Spirobank SpirometerBZG · Traditional | 12/21/1998SE |
Questions and answers
When was Spirotel cleared by the FDA?
Spirotel (K043528) received a 510(k) decision of Substantially Equivalent on July 19, 2005, 210 days after the submission was received.
What is the product code of K043528?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.