510(k) K162503
K162503 is an FDA 510(k) premarket notification submitted by Cardiac Insight, Inc. for the device "Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software". The FDA issued a decision of Substantially Equivalent on Mar 24, 2017. 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
- Mar 24, 2017
- Date Received
- Sep 7, 2016
- 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)