The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Model Micro St Ambulatory Ecg Monitor.
| Device ID | K870537 |
| 510k Number | K870537 |
| Device Name: | MODEL MICRO ST AMBULATORY ECG MONITOR |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | ADVANCED MEDICAL PRODUCTS, INC. FIVE ADLER DR. E. Syracuse, NY 13057 |
| Contact | James H Brown |
| Correspondent | James H Brown ADVANCED MEDICAL PRODUCTS, INC. FIVE ADLER DR. E. Syracuse, NY 13057 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-09 |
| Decision Date | 1987-04-23 |