The following data is part of a premarket notification filed by Premier Heart, Llc. with the FDA for Cardiotron Ekg Multi-phase Information Analysis System, Models 3800, 6800, 8800.
| Device ID | K992703 |
| 510k Number | K992703 |
| Device Name: | CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | PREMIER HEART, LLC. 601 13TH STREET, N.W. SUITE 901 SOUTH Washington, DC 20005 |
| Contact | William D Hare |
| Correspondent | William D Hare PREMIER HEART, LLC. 601 13TH STREET, N.W. SUITE 901 SOUTH Washington, DC 20005 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-12 |
| Decision Date | 2000-03-21 |
| Summary: | summary |