The following data is part of a premarket notification filed by Digicare Biomedical Technology, Inc. with the FDA for Lifewindow Lw8 Lite.
| Device ID | K183687 |
| 510k Number | K183687 |
| Device Name: | LifeWindow LW8 Lite |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Digicare Biomedical Technology, Inc. 107 Commerce Rd. Boynton Beach, FL 33426 |
| Contact | Eduardo Miranda |
| Correspondent | Pedro Miranda Digicare Biomedical Technology, Inc. 107 Commerce Rd. Boynton Beach, FL 33426 |
| Product Code | MWI |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2019-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003504017 | K183687 | 000 |