510(k) K121885
K121885 is an FDA 510(k) premarket notification submitted by Earlysense, Ltd. for the device "EARLYSENSE CENTRAL DISPLAY SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 10, 2012. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Earlysense, Ltd. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 10, 2012
- Date Received
- Jun 28, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)