510(k) K183266
K183266 is an FDA 510(k) premarket notification submitted by Schwarzer Cardiotek GmbH for the device "EP-TRACER System". The FDA issued a decision of Substantially Equivalent on Mar 1, 2019. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2019
- Date Received
- Nov 23, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)