510(k) K093976
K093976 is an FDA 510(k) premarket notification submitted by Proteus Biomedical, Inc. for the device "RAISIN PERSONAL MONITOR". The FDA issued a decision of Substantially Equivalent on Mar 25, 2010. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Proteus Biomedical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 2010
- Date Received
- Dec 24, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type