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 |