RESPIRATORY FLOW MODULE
Device Facts
| Record ID | K833265 |
|---|---|
| Device Name | RESPIRATORY FLOW MODULE |
| Applicant | Thoratec Laboratories Corp. |
| Product Code | JAX · Anesthesiology |
| Decision Date | Nov 28, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2550 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
