The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model Mr-35 Holter Recorder.
| Device ID | K860182 |
| 510k Number | K860182 |
| Device Name: | MODEL MR-35 HOLTER RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | Michael J Smith |
| Correspondent | Michael J Smith OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-21 |
| Decision Date | 1986-02-26 |