B-1000
FDA 510(k) K844226 · Biotrine Corp.
510(k) numberK844226
Submission
- Device name
- B-1000
- Applicant
- Biotrine Corp.
Woburn, MA, US - Received
- November 1, 1984
- Decision date
- November 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K915060 | Astech Home Peak Flow MeterBZH · Traditional | 09/11/1992SE |
| K883704 | Multiichallenge Nebulizer SystemBTI · Traditional | 11/28/1988SE |
| K863134 | Multispiro SA/100BZG · Traditional | 12/15/1986SE |
| K813414 | Peak Flow MonitorBZH · Traditional | 12/31/1981SE |
| K812825 | Flo-Cor IJAX · Traditional | 10/26/1981SE |
Questions and answers
When was B-1000 cleared by the FDA?
B-1000 (K844226) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 19 days after the submission was received.
What is the product code of K844226?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.