510(k) K110809
K110809 is an FDA 510(k) premarket notification submitted by Carefusion 303, Inc. for the device "WIRELESS MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 5, 2011. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Carefusion 303, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 2011
- Date Received
- March 23, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type