The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Cassette Reader.
| Device ID | K811253 |
| 510k Number | K811253 |
| Device Name: | CASSETTE READER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-05 |
| Decision Date | 1981-07-10 |