Ascent Cardiorespiratory Diagnostic Software
FDA 510(k) K242809 · Medical Graphics Corporation
510(k) numberK242809
Submission
- Device name
- Ascent Cardiorespiratory Diagnostic Software
- Applicant
- Medical Graphics Corporation
St. Paul, MN, US - Received
- September 17, 2024
- Decision date
- October 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K260242 | CPETWise PlatformBTY · Traditional | Medibyt , Ltd. | 08/20/2026SE |
| K223629 | SpiroSphere, SpiroSphereECG, CardioSphereBTY · Traditional | Eresearchtechnology GmbH | 05/28/2024SE |
| K231561 | Pulmonary Function Tester, Model: A9BTY · Traditional | Guangzhou Homesun Medical Technology Co., Ltd. | 02/21/2024SE |
| K222982 | Virtus Metabolic MonitorBTY · Traditional | Virtus Technology Aps | 06/23/2023SE |
| K221030 | Model 9100 PFT/DICOBTY · Traditional | Vitalograph Ireland, Ltd. | 07/15/2022SE |
| K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUBTY · Traditional | Eresearchtechnology GmbH | 01/28/2021SE |
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsBTY · Traditional | Cosmed Srl | 02/06/2020SE |
| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | Medical Graphics Corporation | 04/12/2019SE |
| K173937 | SpiroSphereBTY · Traditional | Eresearchtechnology GmbH | 02/15/2019SE |
| K161534 | EasyOne Pro Respiratory Analysis SystemBTY · Traditional | Ndd Medizintechnik AG | 02/22/2017SE |
More from Ndd Medizintechnik AG
| 510(k) | Device | Decision |
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| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | 04/12/2019SE |
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| K070858 | Express SeriesBZL · Special | 04/16/2007SE |
| K061731 | Medgraphics Ultima SystemBZL · Special | 09/06/2006SE |
| K955432 | CPX, CCM, Cath with 15% CO2BZM · Traditional | 07/01/1996SE |
| K943259 | 1085 Ultimate E PlethysmographCCM · Traditional | 04/10/1995SE |
| K923209 | Medgraphics Exercise ConsultBZM · Traditional | 03/11/1993SE |
| K912906 | Medgraphics Pf/DxBZL · Traditional | 02/04/1992SE |
| K896345 | Exercise Evaluation System 2010BZM · Traditional | 01/20/1990SE |
| K896396 | Mida System, Models 1000/1100DYC · Traditional | 01/18/1990SE |
Questions and answers
When was Ascent Cardiorespiratory Diagnostic Software cleared by the FDA?
Ascent Cardiorespiratory Diagnostic Software (K242809) received a 510(k) decision of Substantially Equivalent on October 17, 2024, 30 days after the submission was received.
What is the product code of K242809?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.