Flo-Cor I
FDA 510(k) K812825 · Biotrine Corp.
510(k) numberK812825
Submission
- Device name
- Flo-Cor I
- Applicant
- Biotrine Corp.
Walker, MI, US - Received
- October 8, 1981
- Decision date
- October 26, 1981
- 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 |
| K791730 | Ring-Orifice, Turbulent Flow PneumotJAX · Traditional | Research Development Corp. | 11/16/1979SE |
| K770061 | Vo Respiratory PneumotachographJAX · Traditional | Research Development Corp. | 01/14/1977SE |
More from Research Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K915060 | Astech Home Peak Flow MeterBZH · Traditional | 09/11/1992SE |
| K883704 | Multiichallenge Nebulizer SystemBTI · Traditional | 11/28/1988SE |
| K863134 | Multispiro SA/100BZG · Traditional | 12/15/1986SE |
| K844226 | B-1000BZG · Traditional | 11/20/1984SE |
| K813414 | Peak Flow MonitorBZH · Traditional | 12/31/1981SE |
Questions and answers
When was Flo-Cor I cleared by the FDA?
Flo-Cor I (K812825) received a 510(k) decision of Substantially Equivalent on October 26, 1981, 18 days after the submission was received.
What is the product code of K812825?
The FDA product code is JAX – Pneumotachometer, a Class II (moderate risk) device regulated under 21 CFR 868.2550.