The following data is part of a premarket notification filed by Embla Systems with the FDA for Embletta Mpr.
| Device ID | K122516 |
| 510k Number | K122516 |
| Device Name: | EMBLETTA MPR |
| Classification | Ventilatory Effort Recorder |
| Applicant | EMBLA SYSTEMS 1 HINES RD STE 202 Kanata, CA K2k 3c7 |
| Contact | Jennifer Armstrong |
| Correspondent | Jennifer Armstrong EMBLA SYSTEMS 1 HINES RD STE 202 Kanata, CA K2k 3c7 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2013-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830027434 | K122516 | 000 |
| 00382830024662 | K122516 | 000 |
| 00382830023849 | K122516 | 000 |