Vyntus / SentrySuite Product Line
FDA 510(k) K150810 · Carefusion Germany 234 GmbH
510(k) numberK150810
Submission
- Device name
- Vyntus / SentrySuite Product Line
- Applicant
- Carefusion Germany 234 GmbH
Hoechberg, DE - Received
- March 26, 2015
- Decision date
- August 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
Other 510(k)s with product code BZC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240293 | STSBZC · Traditional | Techbopulm, Ltd. | 09/17/2024SE |
| K183567 | Vyntus/SentrySuite Product LineBZC · Traditional | Vyaire Medical | 08/23/2019SE |
| K190853 | Vyntus BODYBZC · Traditional | Vyaire Medical, Inc. | 08/16/2019SE |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional | Vyaire Medical, Inc. | 11/30/2018SE |
| K162515 | COSMED K5 Wearable Metabolic TechnologyBZC · Traditional | Cosmed Srl | 06/20/2017SE |
| K161295 | MiniBox +BZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 10/21/2016SE |
| K133925 | Vyntus/ Sentrysuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/22/2014SE |
| K133051 | Pulmone Minibox PFT TMBZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 05/02/2014SE |
| K102047 | Lci Option for InnocorBZC · Traditional | Innovision A/S | 11/01/2011SE |
| K072323 | Masterscreen & Oxycon CPXBZC · Special | Viasys Healthcare GmbH | 10/10/2007SE |
More from Viasys Healthcare GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K153654 | Sentry WEB SmartInterpDQK · Traditional | 09/16/2016SE |
| K142959 | Vyntus WalkDQA · Traditional | 03/20/2015SE |
| K141936 | Microblab, MicroloopBZG · Traditional | 12/29/2014SE |
| K133925 | Vyntus/ Sentrysuite Product LineBZC · Traditional | 08/22/2014SE |
| K122699 | Sentrysuite Product LineBTY · Traditional | 11/19/2012SE |
| K113813 | Sentrysuite Product LineBTY · Traditional | 05/10/2012SE |
| K113096 | Micro IBZG · Traditional | 04/13/2012SE |
| K111408 | Microgard IICAH · Traditional | 10/17/2011SE |
| K111053 | Sentrysuite Product LineBTY · Traditional | 08/12/2011SE |
| K101873 | Masterscreen IosBZG · Traditional | 02/10/2011SE |
Questions and answers
When was Vyntus / SentrySuite Product Line cleared by the FDA?
Vyntus / SentrySuite Product Line (K150810) received a 510(k) decision of Substantially Equivalent on August 14, 2015, 141 days after the submission was received.
What is the product code of K150810?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.