The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Model Micro Si Ambulatory Ecg Monitor.
| Device ID | K881905 |
| 510k Number | K881905 |
| Device Name: | MODEL MICRO SI AMBULATORY ECG MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | ADVANCED MEDICAL PRODUCTS, INC. 4709 CROSSROADS PARK DR. Liverpool, NY 13088 |
| Contact | James H Brown |
| Correspondent | James H Brown ADVANCED MEDICAL PRODUCTS, INC. 4709 CROSSROADS PARK DR. Liverpool, NY 13088 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-06 |
| Decision Date | 1988-08-02 |