The following data is part of a premarket notification filed by Oxford Instruments Medical Systems with the FDA for Sonicaid Model Mr-63 Ambulatory Ecg Recorder.
| Device ID | K943862 |
| 510k Number | K943862 |
| Device Name: | SONICAID MODEL MR-63 AMBULATORY ECG RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | OXFORD INSTRUMENTS MEDICAL SYSTEMS 11526 53ND ST. N Clearwater, FL 34620 |
| Contact | Charles Holz |
| Correspondent | Charles Holz OXFORD INSTRUMENTS MEDICAL SYSTEMS 11526 53ND ST. N Clearwater, FL 34620 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1995-06-07 |