The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for E-ram.
| Device ID | K884126 |
| 510k Number | K884126 |
| Device Name: | E-RAM |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | REYNOLDS MEDICAL LTD. 6490 EXCELSIOR BLVD. E-109 Minneapolis, MN 55426 |
| Contact | Terry Suby |
| Correspondent | Terry Suby REYNOLDS MEDICAL LTD. 6490 EXCELSIOR BLVD. E-109 Minneapolis, MN 55426 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1989-10-30 |