The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Pathfinder 3, Auto Surveyor And Surveyor.
| Device ID | K871344 |
| 510k Number | K871344 |
| Device Name: | PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | REYNOLDS MEDICAL LTD. CAWTHORNE HOUSE,51ST ANDREW ST.HERTFORD Herts Sg14 1hz, GB |
| Contact | Armstrong |
| Correspondent | Armstrong REYNOLDS MEDICAL LTD. CAWTHORNE HOUSE,51ST ANDREW ST.HERTFORD Herts Sg14 1hz, GB |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-06 |
| Decision Date | 1987-10-20 |