Pneumotachometer
FDA product code JAX · Class II (moderate risk) · 21 CFR 868.2550 · Anesthesiology
8510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990962 | Flosense, Model 29-8010JAX · Traditional | Sdi Diagnostics, Inc. | 01/07/2000SE |
| K921178 | Pti-A, Pti-P, Pti-N Disposable PneumotachsJAX · Traditional | Medical Associated Services, Inc. | 08/26/1992SE |
| K884464 | Spirometrics Model 2200 SM200 Flow SensorJAX · Traditional | Spirometrics, Inc. | 01/19/1989SE |
| K853085 | Pax MeterJAX · Traditional | Peace Medical, Inc. | 09/03/1985SE |
| K833265 | Respiratory Flow ModuleJAX · Traditional | Thoratec Laboratories Corp. | 11/28/1983SE |
| K812825 | Flo-Cor IJAX · Traditional | Biotrine Corp. | 10/26/1981SE |
| K791730 | Ring-Orifice, Turbulent Flow PneumotJAX · Traditional | Research Development Corp. | 11/16/1979SE |
| K770061 | Vo Respiratory PneumotachographJAX · Traditional | Research Development Corp. | 01/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2678-2014 Class II | No packaging. The device is a computed tomography scanner. Intended to provide corss…When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended… | Philips Medical Systems (Cleveland) Inc | 01/09/2007Terminated |