510(k) K090138
K090138 is an FDA 510(k) premarket notification submitted by Aframe Digital, Inc. for the device "MOBILECARE MONITOR, MODEL 2100". The FDA issued a decision of Substantially Equivalent on April 24, 2009. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400. Aframe Digital, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2009
- Date Received
- January 21, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Bed Patient
- Device Class
- Class I
- Regulation Number
- 880.2400
- Review Panel
- HO
- Submission Type