The following data is part of a premarket notification filed by Advance Medical Device, Inc. with the FDA for Amd Home Health Monitor System And Amd Monitoring Station.
| Device ID | K964697 |
| 510k Number | K964697 |
| Device Name: | AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ADVANCE MEDICAL DEVICE, INC. 152 WEST WISCONSIN AVE. Milwaukee, WI 53203 |
| Contact | Brian W Petersen |
| Correspondent | Brian W Petersen ADVANCE MEDICAL DEVICE, INC. 152 WEST WISCONSIN AVE. Milwaukee, WI 53203 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-22 |
| Decision Date | 1997-02-11 |