The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon #817 Esophageal Multi-probe.
| Device ID | K821890 |
| 510k Number | K821890 |
| Device Name: | CRITIKON #817 ESOPHAGEAL MULTI-PROBE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-25 |
| Decision Date | 1982-08-03 |