The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Vasculab #r12b.
| Device ID | K812608 |
| 510k Number | K812608 |
| Device Name: | VASCULAB #R12B |
| Classification | Recorder, Paper Chart |
| Applicant | MEDASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-15 |
| Decision Date | 1981-10-02 |