Vitalograph Model 7000 Spirotrac
FDA 510(k) K141546 · Vitalograph (Ireland) , Ltd.
510(k) numberK141546
Submission
- Device name
- Vitalograph Model 7000 Spirotrac
- Applicant
- Vitalograph (Ireland) , Ltd.
Ennis, Co. Clare, IE - Received
- June 10, 2014
- Decision date
- September 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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More from Vitalograph Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K223818 | Model 9160 VitaloQUBJEH · Traditional | 05/25/2023SE |
| K221030 | Model 9100 PFT/DICOBTY · Traditional | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | 01/26/2022SE |
| K201562 | SpirotracBZG · Traditional | 10/14/2020SE |
| K200550 | Vitalograph Model 2120 In2itive eDiaryBZG · Traditional | 07/27/2020SE |
| K160253 | Vitalograph Model 6300 microBZG · Traditional | 08/26/2016SE |
| K142642 | Vitalograph Model 6600 CompactBZG · Traditional | 06/30/2015SE |
| K142812 | Vitalograph Model 6800 PneumotracBZG · Traditional | 06/29/2015SE |
| K110525 | Vitalograph Model 7100 - VitalojakDSH · Traditional | 11/23/2011SE |
| K100687 | Vitalograph Hand Held Spirometer, Model 2120BZG · Traditional | 10/16/2010SE |
Questions and answers
When was Vitalograph Model 7000 Spirotrac cleared by the FDA?
Vitalograph Model 7000 Spirotrac (K141546) received a 510(k) decision of Substantially Equivalent on September 3, 2014, 85 days after the submission was received.
What is the product code of K141546?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.