The following data is part of a premarket notification filed by Topera, Inc. with the FDA for Frimap Adapter Connector (mac).
| Device ID | K142182 |
| 510k Number | K142182 |
| Device Name: | FRIMAP ADAPTER CONNECTOR (MAC) |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| 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 | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-08 |
| Decision Date | 2014-09-09 |
| Summary: | summary |