The following data is part of a premarket notification filed by Proteus Digital Health, Inc. with the FDA for Proteus Patch, Ingestible Sensor (accessory).
| Device ID | K131009 |
| 510k Number | K131009 |
| Device Name: | PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) |
| Classification | Ingestible Event Marker |
| Applicant | PROTEUS DIGITAL HEALTH, INC. 2600 BRIDGE PARKWAY, SUITE 101 Redwood City, CA 94065 |
| Contact | Jafar Shenasa |
| Correspondent | Jafar Shenasa PROTEUS DIGITAL HEALTH, INC. 2600 BRIDGE PARKWAY, SUITE 101 Redwood City, CA 94065 |
| Product Code | OZW |
| CFR Regulation Number | 880.6305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-11 |
| Decision Date | 2013-05-07 |
| Summary: | summary |