The following data is part of a premarket notification filed by Topera, Inc. with the FDA for Rhythm View.
| Device ID | K123295 |
| 510k Number | K123295 |
| Device Name: | RHYTHM VIEW |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | TOPERA, INC. 1324 CLARKSON CLAYTON CENTER, #332 Ballwin, MO 63011 |
| Contact | Melissa Walker |
| Correspondent | Melissa Walker TOPERA, INC. 1324 CLARKSON CLAYTON CENTER, #332 Ballwin, MO 63011 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-22 |
| Decision Date | 2013-04-24 |
| Summary: | summary |