Alveo-Diffusion Test
FDA 510(k) K853443 · Erich Jaeger, Inc.
510(k) numberK853443
Submission
- Device name
- Alveo-Diffusion Test
- Applicant
- Erich Jaeger, Inc.
Rockford, IL, US - Received
- August 16, 1985
- Decision date
- February 21, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Innovision A/S
| 510(k) | Device | Decision |
|---|---|---|
| K023120 | Oxycon MobileBZC · Traditional | 11/12/2003SE |
| K023796 | MS Paed-Baby BodyCCM · Special | 03/03/2003SE |
| K021138 | Sleepscreen/Apnoescreen CardioMNR · Traditional | 02/12/2003SE |
| K000396 | Apnoescreen Pro, Alpha Screen ProMNR · Traditional | 12/27/2000SE |
| K001502 | Aerosol Provocation System Aps Pro, Model Aps ProBZC · Special | 07/12/2000SE |
| K000648 | Spiro ProBTY · Special | 03/29/2000SE |
| K980876 | Asthma Monitor AM2BZG · Traditional | 08/14/1998SE |
| K972419 | Toennies Neuroscreen SystemIKN · Traditional | 04/30/1998SE |
| K960078 | Asthma MonitorBZG · Traditional | 09/20/1996SE |
| K954140 | Masterscreen IosBZG · Traditional | 12/14/1995SE |
Questions and answers
When was Alveo-Diffusion Test cleared by the FDA?
Alveo-Diffusion Test (K853443) received a 510(k) decision of Substantially Equivalent on February 21, 1986, 189 days after the submission was received.
What is the product code of K853443?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.