The following data is part of a premarket notification filed by Dymedix, Inc. with the FDA for Dymedix Reusable Airflow/snore Sensor.
| Device ID | K040069 |
| 510k Number | K040069 |
| Device Name: | DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR |
| Classification | Ventilatory Effort Recorder |
| Applicant | DYMEDIX, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-01-14 |
| Decision Date | 2004-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817377022418 | K040069 | 000 |
| 00817377020094 | K040069 | 000 |
| 00817377020087 | K040069 | 000 |
| 00817377020070 | K040069 | 000 |
| 00817377020063 | K040069 | 000 |
| 00817377022777 | K040069 | 000 |