Pneumotachometer
A pneumotachometer is a device used in respiratory physiology to measure airflow rates during breathing by detecting the pressure differential across a low-resistance flow element, providing data for the assessment of pulmonary function. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. The product code is JAX, regulated under 21 CFR 868.2550, within the Anesthesiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JAX
- Device Class
- FDA class 2
- Regulation Number
- 868.2550
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K990962 | FLOSENSE, MODEL 29-8010 | Jan 07, 2000 | Substantially Equivalent | Sdi Diagnostics, Inc. |
| K921178 | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | Aug 26, 1992 | Substantially Equivalent | Medical Associated Services, Inc. |
| K884464 | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Jan 19, 1989 | Substantially Equivalent | Spirometrics, Inc. |
| K853085 | PAX METER | Sep 03, 1985 | Substantially Equivalent | Peace Medical, Inc. |
| K833265 | RESPIRATORY FLOW MODULE | Nov 28, 1983 | Substantially Equivalent | Thoratec Laboratories Corp. |
| K812825 | FLO-COR I | Oct 26, 1981 | Substantially Equivalent | Biotrine Corp. |
| K791730 | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Nov 16, 1979 | Substantially Equivalent | Research Development Corp. |
| K770061 | VO RESPIRATORY PNEUMOTACHOGRAPH | Jan 14, 1977 | Substantially Equivalent | Research Development Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.