MNRClass II
Ventilatory Effort Recorder
21 CFR 868.2375 / Anesthesiology
MNR is the FDA product code for Ventilatory Effort Recorder, a class II device type, regulated under 21 CFR 868.2375. As of , FDA records hold 164 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- MNR
- Device name
- Ventilatory Effort Recorder
- Regulation
- 21 CFR 868.2375
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 165
- Ingested recalls
- 7
Clearances, product code MNR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1995 | 5 |
| 1996 | 1 |
| 1997 | 6 |
| 1998 | 3 |
| 1999 | 5 |
| 2000 | 4 |
| 2001 | 2 |
| 2002 | 6 |
| 2003 | 7 |
| 2004 | 11 |
| 2005 | 3 |
| 2006 | 4 |
| 2007 | 6 |
| 2008 | 14 |
| 2009 | 8 |
| 2011 | 9 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 2 |
| 2015 | 4 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 3 |
| 2019 | 8 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 7 |
| 2023 | 6 |
| 2024 | 6 |
| 2025 | 10 |
| 2026 | 5 |
Applicants with the most clearances
Product code MNR| Applicant | Clearances |
|---|---|
| Itamar Medical | 15 |
| Advanced Brain Monitoring, Inc. | 6 |
| Respironics, Inc. | 6 |
| Snap Laboratories, LLC | 6 |
| Embla Systems | 5 |
| Resmed Germany, Inc. | 5 |
| Compumedics Limited | 4 |
| Huxley Medical | 4 |
| Medcare Flaga | 4 |
| Zephyr Sleep Technologies | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.