JAX — Pneumotachometer Class II
FDA product code JAX covers "Pneumotachometer", a Class II medical device regulated under 21 CFR 868.2550. Submissions are reviewed by the Anesthesiology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JAX
- Device Class
- Class II
- Regulation Number
- 868.2550
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K990962 | Sdi Diagnostics | FLOSENSE, MODEL 29-8010 | Jan 7, 2000 |
| K921178 | Medical Associated Services | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | Aug 26, 1992 |
| K884464 | Spirometrics | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Jan 19, 1989 |
| K853085 | Peace Medical | PAX METER | Sep 3, 1985 |
| K833265 | Thoratec Laboratories | RESPIRATORY FLOW MODULE | Nov 28, 1983 |
| K812825 | Biotrine | FLO-COR I | Oct 26, 1981 |
| K791730 | Research Development | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Nov 16, 1979 |
| K770061 | Research Development | VO RESPIRATORY PNEUMOTACHOGRAPH | Jan 14, 1977 |