Vip Pulmonary Function System
FDA 510(k) K080510 · Viasys Healthcare GmbH
510(k) numberK080510
Submission
- Device name
- Vip Pulmonary Function System
- Applicant
- Viasys Healthcare GmbH
Hoechberg, DE - Received
- February 25, 2008
- Decision date
- August 20, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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| K173937 | SpiroSphereBTY · Traditional | Eresearchtechnology GmbH | 02/15/2019SE |
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| K091505 | COR12+DSH · Traditional | 06/10/2009SE |
| K081823 | Masterscreen Paed - Baby BodyCCM · Traditional | 05/18/2009SE |
| 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 |
| K071753 | Masterscreen Pneumo & MasterscopeBTY · Special | 08/14/2007SE |
| K062011 | Modification to FlowscreenBTY · Special | 05/11/2007SE |
| K070614 | CorscreenDPS · Traditional | 05/04/2007SE |
Questions and answers
When was Vip Pulmonary Function System cleared by the FDA?
Vip Pulmonary Function System (K080510) received a 510(k) decision of Substantially Equivalent on August 20, 2008, 177 days after the submission was received.
What is the product code of K080510?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.