510(k) K141813
K141813 is an FDA 510(k) premarket notification submitted by RhythMedix, LLC for the device "RHYTHMSTAR SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 2014. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. RhythMedix, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2014
- Date Received
- July 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type