The following data is part of a premarket notification filed by Hygieia, Inc with the FDA for D-nav System.
| Device ID | K181916 |
| 510k Number | K181916 |
| Device Name: | D-Nav System |
| Classification | Calculator, Drug Dose |
| Applicant | Hygieia, Inc 28803 8 Mile Rd, Suite 101 Livonia, MI 48152 |
| Contact | Kimberly Chaperon |
| Correspondent | Kimberly Chaperon Hygieia, Inc 28803 8 Mile Rd, Suite 101 Livonia, MI 48152 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-17 |
| Decision Date | 2019-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001044218 | K181916 | 000 |
| 00860001044201 | K181916 | 000 |