Serial Flow
FDA 510(k) K900673 · Spirometrics, Inc.
510(k) numberK900673
Submission
- Device name
- Serial Flow
- Applicant
- Spirometrics, Inc.
Auburn, ME, US - Received
- February 13, 1990
- Decision date
- April 3, 1990
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K915059 | Peak Flow MonitorBZH · Traditional | 07/27/1992SE |
| K911358 | Cmd/Dlco Diagnostic SpirometerBTY · Traditional | 07/22/1991SE |
| K900322 | CO/CMD-1CCJ · Traditional | 04/30/1990SE |
| K901057 | Spirometrics Model 2600 Miro SpirometerBZG · Traditional | 04/03/1990SE |
| K884464 | Spirometrics Model 2200 SM200 Flow SensorJAX · Traditional | 01/19/1989SE |
| K884465 | Spirometrics Model 2141 Spiro-Filter(Tm)CAH · Traditional | 11/09/1988SE |
| K863953 | Spirometrics Model 2500 Flowmate(Tm)BZM · Traditional | 01/15/1987SE |
| K850045 | Spirometrics 2453 & Smi IIIBTY · Traditional | 02/14/1985SE |
| K844333 | Spirometrics 2451 & Smi IBZG · Traditional | 11/20/1984SE |
| K831497 | Spirometrics Breon 2400 & Smi 2400BZG · Traditional | 06/24/1983SE |
Questions and answers
When was Serial Flow cleared by the FDA?
Serial Flow (K900673) received a 510(k) decision of Substantially Equivalent on April 3, 1990, 49 days after the submission was received.
What is the product code of K900673?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.