The following data is part of a premarket notification filed by Topera, Inc. with the FDA for Rhythmview (tm).
| Device ID | K110878 |
| 510k Number | K110878 |
| Device Name: | RHYTHMVIEW (TM) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | TOPERA, INC. 11445 E. VIA LINDA SUITE 2, P.O. BOX 224 Scottsdale, AZ 85259 |
| Contact | Ruchir Sehra |
| Correspondent | Ruchir Sehra TOPERA, INC. 11445 E. VIA LINDA SUITE 2, P.O. BOX 224 Scottsdale, AZ 85259 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-30 |
| Decision Date | 2011-09-23 |
| Summary: | summary |