Cardiotech Spirometry System, Model GT-105
FDA 510(k) K090646 · Chest M.I., Inc.
510(k) numberK090646
Submission
- Device name
- Cardiotech Spirometry System, Model GT-105
- Applicant
- Chest M.I., Inc.
Austin, TX, US - Received
- March 11, 2009
- Decision date
- July 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
|---|---|---|
| K080921 | Spiro-Master PC-10 Spirometry SystemBZG · Traditional | 01/21/2009SE |
Questions and answers
When was Cardiotech Spirometry System, Model GT-105 cleared by the FDA?
Cardiotech Spirometry System, Model GT-105 (K090646) received a 510(k) decision of Substantially Equivalent on July 23, 2009, 134 days after the submission was received.
What is the product code of K090646?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.