The following data is part of a premarket notification filed by Topera, Inc. with the FDA for Rhythmview Workstation.
| Device ID | K142901 |
| 510k Number | K142901 |
| Device Name: | RhythmView Workstation |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Topera, Inc. 3668 S. Geyer Road, Suite 365 St. Louis, MO 63127 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo Topera, Inc. 3668 S. Geyer Road, Suite 365 St. Louis, MO 63127 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2014-12-19 |
| Summary: | summary |