Clearance Summary
MOBILECARE MONITOR, MODEL 2100 received FDA 510(k) clearance under submission number K090138, sponsored by Aframe Digital, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-04-24.
- Submission: K090138
- Applicant / Sponsor: Aframe Digital, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 2009-04-24
Classification & Regulation
This clearance is catalogued under FDA product code KMI and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.