510(k) K231416
- Device
- Air Next (NVD-02)
- Applicant
- Nuvoair AB
- 510(k) number
- K231416
- Product code
- BZG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-18
- Date received
- 2023-05-16
- Regulation
- 868.1840
- Classification name
- Spirometer, Diagnostic
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Furat Shawki
- Address
- 17d Riddargatan Stockholm, SE 11457 Stockholm SE
FDA Registration Numbers#
- 3010272829
- 3003630525
- 3010594620
- 3009443693
- 3011861727
- 3033536319
- 3012821221
- 9680602
- 9614485
- 3006895489
- 3008505660
- 3012302888
- 3008317830
- 3018783526
- 3003681187
- 3013188547
- 3015134004
- 3011707784
- 1832562
- 3006419626
- 8021084
- 3014916466
- 3013744763
- 9614860
- 3012250536
- 1220253
- 9610849
- 3011359729
- 3011269086
- 8030978
- 3003318787
- 3004050971
- 3005855942
- 3010082909
- 3008717264
- 3006087789
- 3007648426
- 3010838917
- 3023272766
- 3030733800
- 1718873
- 3004748541
- 3008935567
- 3018188848
- 3004428458
- 3027510187
- 3006254047
- 1316463
- 3013298431
- 2518422
- 2434982
- 3010381606
- 3006288727
- 3007583504
- 3006673317
- 1000604079
- 3012494290
- 2133810
- 3000126629
- 9615102
- 3011583549
- 3012026312
- 3009509998
- 3006795797
- 3002808458
- 3007128724
- 3036774597
- 2022648
- 3005053770
- 2433214
- 3030447506
- 3008412416
- 3013896610
- 3030446844
- 3007113169
- 8020893
- 3004035727
- 3018116884
- 3014579161
Source Documents#
Other 510(k) Records For Product Code BZG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | 2026-03-02 |
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | 2024-11-20 |
| K230501 | Spirobank Oxi | Mir Medical International Research USA | 2023-12-15 |
| K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | 2023-10-19 |
| K222525 | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | 2023-08-28 |
| K222443 | Air Smart Extra Spirometer | Feellife Health, Inc. | 2023-08-09 |
| K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | 2023-06-12 |
| K213872 | ComPAS2 | Morgan Scientific, Inc. | 2022-07-15 |
| K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022-01-26 |
| K201493 | Spirometer | Mehow Innovative, Ltd. | 2021-06-10 |
| K202837 | GoSpiro | Monitored Therapeutics, Inc. | 2020-12-04 |
| K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020-10-14 |
| K201002 | Safey Pocket Spirometer | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020-07-27 |
| K183089 | Air Next | Nuvoair AB | 2020-01-02 |