JAX · Pneumotachometer
Anesthesiology · 21 CFR 868.2550 · Class 2
Overview
| Product Code | JAX |
|---|---|
| Device Name | Pneumotachometer |
| Regulation | 21 CFR 868.2550 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990962 | FLOSENSE, MODEL 29-8010 | Sdi Diagnostics, Inc. | Jan 7, 2000 | SESE |
| K921178 | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | Medical Associated Services, Inc. | Aug 26, 1992 | SESE |
| K884464 | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Spirometrics, Inc. | Jan 19, 1989 | SESE |
| K853085 | PAX METER | Peace Medical, Inc. | Sep 3, 1985 | SESE |
| K833265 | RESPIRATORY FLOW MODULE | Thoratec Laboratories Corp. | Nov 28, 1983 | SESE |
| K812825 | FLO-COR I | Biotrine Corp. | Oct 26, 1981 | SESE |
| K791730 | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Research Development Corp. | Nov 16, 1979 | SESE |
| K770061 | VO RESPIRATORY PNEUMOTACHOGRAPH | Research Development Corp. | Jan 14, 1977 | SESE |
Top Applicants
- Research Development Corp. — 2 clearances
- Thoratec Laboratories Corp. — 1 clearance
- Spirometrics, Inc. — 1 clearance
- Sdi Diagnostics, Inc. — 1 clearance
- Peace Medical, Inc. — 1 clearance
