The following data is part of a premarket notification filed by Decisio Health, Inc. with the FDA for Decisio Health Patient Dashboard.
| Device ID | K142106 |
| 510k Number | K142106 |
| Device Name: | DECISIO HEALTH PATIENT DASHBOARD |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | DECISIO HEALTH, INC. 755 N. MATHILDA AVENUE, SUITE 100 Sunnyvale, CA 94085 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren DECISIO HEALTH, INC. 755 N. MATHILDA AVENUE, SUITE 100 Sunnyvale, CA 94085 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2015-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865683000309 | K142106 | 000 |