The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for Disposable Esophageal Stethoscope.
| Device ID | K973839 |
| 510k Number | K973839 |
| Device Name: | DISPOSABLE ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | John A Steen, Ph.d. |
| Correspondent | John A Steen, Ph.d. CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-08 |
| Decision Date | 1998-03-19 |