The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Vasculab #vsc21.
| Device ID | K812609 |
| 510k Number | K812609 |
| Device Name: | VASCULAB #VSC21 |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | MEDASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-15 |
| Decision Date | 1981-10-02 |