The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Signal-averaged High Resolution P Wave Analysis.
| Device ID | K972199 |
| 510k Number | K972199 |
| Device Name: | SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS |
| Classification | Electrocardiograph |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Kristin Pabst |
| Correspondent | Kristin Pabst MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-11 |
| Decision Date | 1997-09-25 |
| Summary: | summary |