The following data is part of a premarket notification filed by Topera, Inc. with the FDA for Rhythm View Workstation (non-streaming, Steaming Option).
| Device ID | K151245 |
| 510k Number | K151245 |
| Device Name: | Rhythm View Workstation (non-streaming, Steaming Option) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | TOPERA, INC. 1530 OBRIEN DR., SUITE A Menlo Park, CA 94025 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-11 |
| Decision Date | 2015-09-15 |
| Summary: | summary |