Clearance Summary
PROTEUS INGESTION CONFINMATION SYSTEMS received FDA 510(k) clearance under submission number DEN120011, sponsored by Proteus Biomedical, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-07-10.
- Submission: DEN120011
- Applicant / Sponsor: Proteus Biomedical, Inc.
- Clearance pathway: Post-NSE
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6305
- Decision date: 2012-07-10
Classification & Regulation
This clearance is catalogued under FDA product code OZW and 21 CFR 880.6305, within the General Hospital review panel as a Class II device.