Vitalograph Spirotrac III
FDA 510(k) K912412 · Vitalograph , Ltd.
510(k) numberK912412
Submission
- Device name
- Vitalograph Spirotrac III
- Applicant
- Vitalograph , Ltd.
Lenexa, KS, US - Received
- May 31, 1991
- Decision date
- October 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
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| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
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| 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 |
|---|---|---|
| K253293 | VitaloJAK Clinic (Model 7100)DSH · Special | 12/03/2025SE |
| K000599 | Vitalograph Base StationBZG · Traditional | 09/08/2000SE |
| K991412 | Vitalograph MicroBZH · Traditional | 02/04/2000SE |
| K943678 | Electronic Flow MeterBZH · Traditional | 12/14/1995SE |
| K950854 | Vitalograph 2110 Software InterfaceDSH · Traditional | 10/12/1995SE |
| K946075 | Vitalograph Model 2120BZG · Traditional | 08/04/1995SE |
| K942779 | Disposable Bacteriological FilterBZG · Traditional | 07/13/1994SE |
| K925085 | Escort SpirometerBZG · Traditional | 08/12/1993SE |
| K930085 | Vitalograph Data Storage SpirometerBTY · Traditional | 07/26/1993SE |
| K893665 | Aerosol Inhalation MonitorBWF · Traditional | 08/21/1989SE |
Questions and answers
When was Vitalograph Spirotrac III cleared by the FDA?
Vitalograph Spirotrac III (K912412) received a 510(k) decision of Substantially Equivalent on October 15, 1991, 137 days after the submission was received.
What is the product code of K912412?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.