The following data is part of a premarket notification filed by Bruce Franklin, Inc. with the FDA for Franklin Quantic 1200.
| Device ID | K822236 |
| 510k Number | K822236 |
| Device Name: | FRANKLIN QUANTIC 1200 |
| Classification | Echocardiograph |
| Applicant | BRUCE FRANKLIN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-28 |
| Decision Date | 1982-08-31 |