The following data is part of a premarket notification filed by Lumedx with the FDA for Healthview Ecg Manager.
| Device ID | K123466 |
| 510k Number | K123466 |
| Device Name: | HEALTHVIEW ECG MANAGER |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | LUMEDX 110 110TH AVE NE SUITE 475 Bellevue, WA 98004 |
| Contact | Chris Pearce |
| Correspondent | Chris Pearce LUMEDX 110 110TH AVE NE SUITE 475 Bellevue, WA 98004 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-09 |
| Decision Date | 2012-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857560008010 | K123466 | 000 |