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 |