The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Impact (informing Mobile Personnel And Care Tracking) Pager System.
| Device ID | K971868 |
| 510k Number | K971868 |
| Device Name: | IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Dianne Schmitz |
| Correspondent | Dianne Schmitz MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-20 |
| Decision Date | 1997-11-13 |
| Summary: | summary |