The following data is part of a premarket notification filed by Advanced Medical Devices, Inc. with the FDA for Amd Home Health Monitoring System.
| Device ID | K960337 |
| 510k Number | K960337 |
| Device Name: | AMD HOME HEALTH MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ADVANCED MEDICAL DEVICES, INC. 152 WEST WISCONSIN AVE. SUITE 930 Milwaukee, WI 53203 |
| Contact | Brian W Petersen |
| Correspondent | Brian W Petersen ADVANCED MEDICAL DEVICES, INC. 152 WEST WISCONSIN AVE. SUITE 930 Milwaukee, WI 53203 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-24 |
| Decision Date | 1996-09-24 |
| Summary: | summary |