The following data is part of a premarket notification filed by Embla Systems with the FDA for Disposable Breathsensor Adult, Disposable Breathsensor Small Adult / Child, Disposable Breathsensor Preemie, Disposable Breathsensor Infant.
| Device ID | K180001 |
| 510k Number | K180001 |
| Device Name: | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant |
| Classification | Ventilatory Effort Recorder |
| Applicant | Embla Systems 1 Hines Road Suite 202 Kanata, CA K2k 3c7 |
| Contact | Sanjay Mehta |
| Correspondent | Sanjay Mehta Embla Systems 1 Hines Road Suite 202 Kanata, CA K2k 3c7 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2019-09-27 |
| Summary: | summary |