The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Esophageal Stethoscope Temperature Probe.
| Device ID | K810147 |
| 510k Number | K810147 |
| Device Name: | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | PORTEX, INC. 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 | 1981-01-21 |
| Decision Date | 1981-02-05 |