EKG SPEAKS
Analyzer, Pacemaker Generator Function, Indirect
MEDTRONIC VASCULAR
The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Ekg Speaks.
Pre-market Notification Details
| Device ID | K032926 |
| 510k Number | K032926 |
| Device Name: | EKG SPEAKS |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Contact | Kristyn Benson |
| Correspondent | Kristyn Benson MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Product Code | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-10-15 |
| Summary: | summary |
Trademark Results [EKG SPEAKS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EKG SPEAKS 75700956 2393076 Dead/Cancelled |
Paceart Associates, L.P. 1999-05-07 |
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