The following data is part of a premarket notification filed by Abbott Electrophysiology with the FDA for Rhythmview Workstation.
Device ID | K171583 |
510k Number | K171583 |
Device Name: | RhythmView Workstation |
Classification | Computer, Diagnostic, Programmable |
Applicant | Abbott Electrophysiology 1530 Obrien Drive, Suite B Menlo Park, CA 94025 |
Contact | Dennis Pozzo |
Correspondent | Dennis Pozzo Abbott Electrophysiology 3668 S. Geyer Road, Suite 365 St. Louis, MO 63127 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-31 |
Decision Date | 2017-09-01 |
Summary: | summary |