The following data is part of a premarket notification filed by Proteus Digital Health, Inc. with the FDA for Proteus Digital Health Feedback Device.
| Device ID | K150494 |
| 510k Number | K150494 |
| Device Name: | Proteus Digital Health Feedback Device |
| Classification | Ingestible Event Marker |
| Applicant | PROTEUS DIGITAL HEALTH, INC. 2600 BRIDGE PARKWAY, SUITE 101 Redwood City, CA 94065 |
| Contact | Jessie Duong |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-25 |
| Decision Date | 2015-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856602005222 | K150494 | 000 |
| 10856602005175 | K150494 | 000 |
| 10856602005182 | K150494 | 000 |
| 10856602005199 | K150494 | 000 |
| 10856602005205 | K150494 | 000 |
| 10856602005236 | K150494 | 000 |
| 10856602005243 | K150494 | 000 |
| 10856602005250 | K150494 | 000 |
| 10856602005267 | K150494 | 000 |
| 10856602005274 | K150494 | 000 |
| 20856602005172 | K150494 | 000 |
| 10856602005137 | K150494 | 000 |
| 00856602005154 | K150494 | 000 |
| 00856602005215 | K150494 | 000 |
| 10856602005168 | K150494 | 000 |