The following data is part of a premarket notification filed by Proteus Digital Health, Inc. with the FDA for Proteus Patch, Proteus Ingestible Sensor (accessory).
| Device ID | K133263 |
| 510k Number | K133263 |
| Device Name: | PROTEUS PATCH, PROTEUS 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 | 2013-10-23 |
| Decision Date | 2014-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856602005014 | K133263 | 000 |
| 10856602005045 | K133263 | 000 |
| 10856602005052 | K133263 | 000 |
| 10856602005069 | K133263 | 000 |
| 10856602005076 | K133263 | 000 |
| 10856602005083 | K133263 | 000 |
| 10856602005090 | K133263 | 000 |
| 10856602005106 | K133263 | 000 |
| 10856602005113 | K133263 | 000 |
| 10856602005120 | K133263 | 000 |
| 10856602005021 | K133263 | 000 |