510(k) K142468
K142468 is an FDA 510(k) premarket notification submitted by Cardiac Insight, Inc. for the device "Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System". The FDA issued a decision of Substantially Equivalent on Jul 11, 2015. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Cardiac Insight, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 2015
- Date Received
- Sep 3, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type
- 510(k)