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 |