Panels › Anesthesiology › Product code MNR · Class 2
Ventilatory Effort Recorder
Regulation 868.2375
6510(k)s in 12 months (165 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in MNR
| Company | 510(k)s | Recalls |
|---|---|---|
| Itamar Medical | 15 | 0 |
| Respironics, Inc. | 6 | 2 |
| Advanced Brain Monitoring | 6 | 0 |
| Snap Laboratories, LLC | 6 | 0 |
| Compumedics Limited | 5 | 0 |
| Embla Systems | 5 | 0 |
| Resmed Germany, Inc. | 5 | 0 |
| Huxley Medical | 4 | 0 |
| Medcare Flaga | 4 | 0 |
| Somnomedics GmbH | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2021 | NOX MEDICAL Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep. Terminated |
MNR | K082113 |
| Jul 11, 2013 | SagaTech Electronics, Inc. Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder)
To be used to gather heart rate and blood oxygen data during a sleep study. Terminated |
MNR | K002159 |
| Jun 11, 2013 | Embla System Llc embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder).
The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis Terminated |
MNR | K073682 |
| Jan 11, 2012 | Del Mar Reynolds Medical, Ltd. Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31.
Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea Terminated |
MNR | K042745 |
| Sep 19, 2010 | Ventus Medical, Inc. The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy d Terminated |
MNR | K080983 |
| Apr 24, 2008 | Respironics, Inc. Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNR | K052573 |
| Apr 24, 2008 | Respironics, Inc. Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNR | K052573 |
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