The following data is part of a premarket notification filed by Embla Systems, Inc. with the FDA for Embletta Gold.
| Device ID | K073682 |
| 510k Number | K073682 |
| Device Name: | EMBLETTA GOLD |
| Classification | Ventilatory Effort Recorder |
| Applicant | EMBLA SYSTEMS, INC. 11001 W. 120TH AVE. Broomfield, CO 80021 |
| Contact | Robert G Schueppert |
| Correspondent | Robert G Schueppert EMBLA SYSTEMS, INC. 11001 W. 120TH AVE. Broomfield, CO 80021 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-08-08 |
| Summary: | summary |