Vo Respiratory Pneumotachograph
FDA 510(k) K770061 · Research Development Corp.
510(k) numberK770061
Submission
- Device name
- Vo Respiratory Pneumotachograph
- Applicant
- Research Development Corp.
Mchenry, IL, US - Received
- January 11, 1977
- Decision date
- January 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JAX – Pneumotachometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2550
- Specialty
- Anesthesiology
Other 510(k)s with product code JAX
| 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 |
More from Research Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K871870 | HSC Unit RodKWP · Traditional | 07/21/1987SE |
| K791730 | Ring-Orifice, Turbulent Flow PneumotJAX · Traditional | 11/16/1979SE |
| K771407 | Lung Volume & Pressure MonitorBZQ · Traditional | 08/04/1977SE |
| K771019 | Lung-Mechanics MonitorBZQ · Traditional | 06/14/1977SE |
| K770785 | Monitor, Respiratory, Two-Gas, RDCKLA · Traditional | 05/20/1977SE |
Questions and answers
When was Vo Respiratory Pneumotachograph cleared by the FDA?
Vo Respiratory Pneumotachograph (K770061) received a 510(k) decision of Substantially Equivalent on January 14, 1977, 3 days after the submission was received.
What is the product code of K770061?
The FDA product code is JAX – Pneumotachometer, a Class II (moderate risk) device regulated under 21 CFR 868.2550.