The following data is part of a premarket notification filed by Spelna, Inc. with the FDA for Medilac #sr4 & Sr 40.
| Device ID | K820256 |
| 510k Number | K820256 |
| Device Name: | MEDILAC #SR4 & SR 40 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | SPELNA, INC. 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 | 1982-01-29 |
| Decision Date | 1982-06-25 |