Flosense, Model 29-8010
FDA 510(k) K990962 · Sdi Diagnostics, Inc.
510(k) numberK990962
Submission
- Device name
- Flosense, Model 29-8010
- Applicant
- Sdi Diagnostics, Inc.
Easton, MA, US - Received
- March 22, 1999
- Decision date
- January 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
More from Research Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K150515 | IQSense Flow Sensor MouthpieceBZG · Traditional | 01/12/2016SE |
| K092813 | Astrasonic Spirometer, Model 29-8000BZG · Traditional | 07/16/2010SE |
| K061571 | Astra 300BZG · Traditional | 01/31/2007SE |
| K062913 | Astraguard Pulmonary Function FilterBZG · Traditional | 01/26/2007SE |
| K033939 | Flosense II, Model 29-8040BZG · Traditional | 01/30/2004SE |
| K031643 | Spirotel, Model 29-1020BZG · Traditional | 12/09/2003SE |
| K013812 | Spirolab II, Model 29BZG · Traditional | 02/11/2002SE |
| K011470 | Sdi SB Office, Model 29-BZG · Traditional | 10/12/2001SE |
| K934509 | Pulmoguard Disposable Baterial/Viral FilterCAH · Traditional | 10/21/1993SE |
Questions and answers
When was Flosense, Model 29-8010 cleared by the FDA?
Flosense, Model 29-8010 (K990962) received a 510(k) decision of Substantially Equivalent on January 7, 2000, 291 days after the submission was received.
What is the product code of K990962?
The FDA product code is JAX – Pneumotachometer, a Class II (moderate risk) device regulated under 21 CFR 868.2550.