Masterscreen Pneumo & Masterscope
FDA 510(k) K071753 · Viasys Healthcare GmbH
510(k) numberK071753
Submission
- Device name
- Masterscreen Pneumo & Masterscope
- Applicant
- Viasys Healthcare GmbH
Yorba Linda, CA, US - Received
- June 28, 2007
- Decision date
- August 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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| K242809 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | Medical Graphics Corporation | 10/17/2024SE |
| 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 |
More from Eresearchtechnology GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K092324 | SpiroproDQA · Special | 09/03/2009SE |
| K091412 | Clean Peak Flow MeterBZH · Special | 08/21/2009SE |
| K091505 | COR12+DSH · Traditional | 06/10/2009SE |
| K081823 | Masterscreen Paed - Baby BodyCCM · Traditional | 05/18/2009SE |
| K080510 | Vip Pulmonary Function SystemBTY · Special | 08/20/2008SE |
| K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CTBTY · Traditional | 06/26/2008SE |
| K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodyJEH · Traditional | 04/22/2008SE |
| K072323 | Masterscreen & Oxycon CPXBZC · Special | 10/10/2007SE |
| K062011 | Modification to FlowscreenBTY · Special | 05/11/2007SE |
| K070614 | CorscreenDPS · Traditional | 05/04/2007SE |
Questions and answers
When was Masterscreen Pneumo & Masterscope cleared by the FDA?
Masterscreen Pneumo & Masterscope (K071753) received a 510(k) decision of Substantially Equivalent on August 14, 2007, 47 days after the submission was received.
What is the product code of K071753?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.