Product code JAX
- Device name
- Pneumotachometer
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2550
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990962 | FLOSENSE, MODEL 29-8010 | Sdi Diagnostics, Inc. | 2000-01-07 |
| K921178 | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | Medical Associated Services, Inc. | 1992-08-26 |
| K884464 | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Spirometrics, Inc. | 1989-01-19 |
| K853085 | PAX METER | Peace Medical, Inc. | 1985-09-03 |
| K833265 | RESPIRATORY FLOW MODULE | Thoratec Laboratories Corp. | 1983-11-28 |
| K812825 | FLO-COR I | Biotrine Corp. | 1981-10-26 |
| K791730 | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Research Development Corp. | 1979-11-16 |
| K770061 | VO RESPIRATORY PNEUMOTACHOGRAPH | Research Development Corp. | 1977-01-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00817136026541 | 3830 | HANS RUDOLPH, INC. | 2021-04-06 |
| 00817136026374 | 3830 | HANS RUDOLPH, INC. | 2020-11-20 |
| 00850008733048 | Accutach Flow Sensor | B&B Medical Technologies | 2019-07-18 |
| 00817136026220 | 8311 PNT | HANS RUDOLPH, INC. | 2019-07-18 |
| 00810016250814 | MGC Diagnostics | MEDICAL GRAPHICS CORPORATION | 2019-03-31 |
| 00810016250821 | MGC Diagnostics | MEDICAL GRAPHICS CORPORATION | 2019-03-31 |
| 00810016250838 | MGC Diagnsotics | MEDICAL GRAPHICS CORPORATION | 2019-02-22 |
| B279298010K1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298021K1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298021F1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298020K1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298020F1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298012K1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298012F1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298011K | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298011F | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279298010F1 | FloSense | S D I DIAGNOSTICS INC | 2017-02-11 |
| B279DP2111 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2011 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2001 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2000 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2002 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2010 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2012 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| DP2110 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2112 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2504 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2507 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279DP2514 | FloSense | S D I DIAGNOSTICS INC | 2016-09-09 |
| B279S298010 | FloSense | S D I DIAGNOSTICS INC | 2016-07-26 |