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 |