The following data is part of a premarket notification filed by Medeia, Inc. with the FDA for Vitalscan Ans.
| Device ID | K191266 |
| 510k Number | K191266 |
| Device Name: | VitalScan ANS |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | Medeia, Inc. 7 W Figueroa Street, Suites 300 Santa Barbara, CA 93101 |
| Contact | Slav Danev |
| Correspondent | Daniel Lehtonen Compliance And Regulatory Services LLC 3771 Southbrook Dr Dayton, OH 45430 |
| Product Code | JOM |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2020-01-15 |