The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Pathfinder 700 Holter Analyzer.
| Device ID | K951902 |
| 510k Number | K951902 |
| Device Name: | PATHFINDER 700 HOLTER ANALYZER |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | REYNOLDS MEDICAL LTD. 201 ROUTE 17 Rutherford, NJ 07070 |
| Contact | George Myers |
| Correspondent | George Myers REYNOLDS MEDICAL LTD. 201 ROUTE 17 Rutherford, NJ 07070 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1996-07-15 |
| Summary: | summary |