The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Cardio-esophascope.
| Device ID | K830716 |
| 510k Number | K830716 |
| Device Name: | CARDIO-ESOPHASCOPE |
| 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 | 1983-03-08 |
| Decision Date | 1983-08-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CARDIO-ESOPHASCOPE 73444762 1376465 Dead/Cancelled |
PORTEX, INC. 1983-09-21 |