The following data is part of a premarket notification filed by Hoffrel Instruments, Inc. with the FDA for Ultrasonic Diagnostic System, Mod. 202.
| Device ID | K800364 |
| 510k Number | K800364 |
| Device Name: | ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 |
| Classification | Thin Layer Chromatography, Barbiturate |
| Applicant | HOFFREL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DKX |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-20 |
| Decision Date | 1980-03-12 |