510(k) K173837
K173837 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "RHYTHMIA HDx Mapping System (with software Version 2.0)". The FDA issued a decision of Substantially Equivalent on Jul 25, 2018. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 25, 2018
- Date Received
- Dec 18, 2017
- Clearance Type
- Traditional
- 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)