The following data is part of a premarket notification filed by Makromed, Inc. with the FDA for Cloudekg.
| Device ID | K130878 |
| 510k Number | K130878 |
| Device Name: | CLOUDEKG |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MAKROMED, INC. 88 STILES ROAD Salem, NH 03079 |
| Contact | Barry V Ashar |
| Correspondent | Barry V Ashar MAKROMED, INC. 88 STILES ROAD Salem, NH 03079 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2014-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04650075330081 | K130878 | 000 |