Oxycon Pro
FDA 510(k) K992214 · Erich Jaeger B.V.
510(k) numberK992214
Submission
- Device name
- Oxycon Pro
- Applicant
- Erich Jaeger B.V.
Nl-3981 La Bunnik, NL - Received
- July 1, 1999
- Decision date
- February 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
| 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 |
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Questions and answers
When was Oxycon Pro cleared by the FDA?
Oxycon Pro (K992214) received a 510(k) decision of Substantially Equivalent on February 22, 2000, 236 days after the submission was received.
What is the product code of K992214?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.