The following data is part of a premarket notification filed by Medcare Flaga with the FDA for Embla N7000.
| Device ID | K024322 |
| 510k Number | K024322 |
| Device Name: | EMBLA N7000 |
| Classification | Ventilatory Effort Recorder |
| Applicant | MEDCARE FLAGA 46 LOCH HAVEN LN. Battle Creek, MI 49015 |
| Contact | Kumar Kulkarni |
| Correspondent | Kumar Kulkarni MEDCARE FLAGA 46 LOCH HAVEN LN. Battle Creek, MI 49015 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-26 |
| Decision Date | 2003-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830026789 | K024322 | 000 |
| 00382830026772 | K024322 | 000 |
| 00382830025393 | K024322 | 000 |
| 00382830025386 | K024322 | 000 |
| 00382830025379 | K024322 | 000 |
| 00382830025362 | K024322 | 000 |
| 00382830025348 | K024322 | 000 |
| 00382830024655 | K024322 | 000 |