Model 9160 VitaloQUB
FDA 510(k) K223818 · Vitalograph Ireland, Ltd.
510(k) numberK223818
Submission
- Device name
- Model 9160 VitaloQUB
- Applicant
- Vitalograph Ireland, Ltd.
Ennis Co Clare, IE - Received
- December 21, 2022
- Decision date
- May 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JEH – Plethysmograph, Volume
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1760
- Specialty
- Anesthesiology
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| K022636 | Body Box 5500JEH · Traditional | Morgan Scientific, Inc. | 01/13/2003SE |
| K960840 | C.E. Vascular MachineJEH · Traditional | C.E. Diagnosis, Inc. | 03/28/1997SE |
| K953642 | AP-18JEH · Traditional | Jeneric/Pentron, Inc. | 12/12/1995SE |
| K951901 | Masterscreen PFT BodyJEH · Traditional | Erich Jaeger GmbH & Co. KG | 07/31/1995SE |
| K936108 | Masterscreen BodyJEH · Traditional | Erich Jaeger GmbH & Co. KG | 02/03/1995SE |
| K932812 | Ec 5R PlethysmographJEH · Traditional | D. E. Hokanson, Inc. | 01/13/1994SE |
| K925040 | TelepulseJEH · Traditional | Biometrix , Ltd. | 08/23/1993SE |
| K851197 | Cybermedic CM-810 Body PlethysmographJEH · Traditional | Cybermedic, Inc. | 07/08/1985SE |
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|---|---|---|
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| 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 |
| K141546 | Vitalograph Model 7000 SpirotracBZG · Traditional | 09/03/2014SE |
| 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 Model 9160 VitaloQUB cleared by the FDA?
Model 9160 VitaloQUB (K223818) received a 510(k) decision of Substantially Equivalent on May 25, 2023, 155 days after the submission was received.
What is the product code of K223818?
The FDA product code is JEH – Plethysmograph, Volume, a Class II (moderate risk) device regulated under 21 CFR 868.1760.