The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Sonicaid Model D206e Air Emboli-detect.
| Device ID | K833227 |
| 510k Number | K833227 |
| Device Name: | SONICAID MODEL D206E AIR EMBOLI-DETECT |
| Classification | Procainamide Control Materials |
| Applicant | SONICAID, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBA |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-16 |
| Decision Date | 1983-10-27 |