Spiro Scan
FDA 510(k) K851135 · Brentwood Instruments, Inc.
510(k) numberK851135
Submission
- Device name
- Spiro Scan
- Applicant
- Brentwood Instruments, Inc.
Torrance, CA, US - Received
- March 21, 1985
- Decision date
- July 1, 1985
- 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 |
|---|---|---|
| K896924 | Spiroscan 4000BZG · Traditional | 03/01/1990SE |
| K882366 | Rhythmscan HR Holter RecorderDSH · Traditional | 08/02/1988SE |
| K871572 | RhythmscanDSI · Traditional | 02/22/1988SE |
| K860024 | Fukuda Denshi Cardimax FCP-211DSI · Traditional | 03/31/1986SE |
| K853979 | Cardimax FX-1164DPS · Traditional | 02/06/1986SE |
| K854505 | Cardimax FX-406UDRS · Traditional | 02/04/1986SE |
| K851124 | T-1000 ECG TransmitterDXH · Traditional | 05/15/1985SE |
| K851123 | R-1000 ECG ReceiverDXH · Traditional | 05/15/1985SE |
| K842976 | Brentwood Ez Scan 200 Ambulatory ECGDSI · Traditional | 03/01/1985SE |
| K844470 | Fukuda Denshi Model FCP-220DPS · Traditional | 01/10/1985SE |
Questions and answers
When was Spiro Scan cleared by the FDA?
Spiro Scan (K851135) received a 510(k) decision of Substantially Equivalent on July 1, 1985, 102 days after the submission was received.
What is the product code of K851135?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.