The following data is part of a premarket notification filed by Proteus Biomedical, Inc. with the FDA for Raisin Personal Monitor.
| Device ID | K093976 |
| 510k Number | K093976 |
| Device Name: | RAISIN PERSONAL MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | PROTEUS BIOMEDICAL, INC. 2600 BRIDGE PARKWAY SUITE 101 Redwood City, CA 94065 |
| Contact | Gregory Moon |
| Correspondent | Gregory Moon PROTEUS BIOMEDICAL, INC. 2600 BRIDGE PARKWAY SUITE 101 Redwood City, CA 94065 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-03-25 |
| Summary: | summary |