The following data is part of a premarket notification filed by Arzco Medical Electronics, Inc. with the FDA for Tapscope Esophageal Cardiac Recording Stethoscope.
| Device ID | K904943 |
| 510k Number | K904943 |
| Device Name: | TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | ARZCO MEDICAL ELECTRONICS, INC. 1029 BUTTERFIELD RD. (DUPLICATE/1927197) Vernon Hills, IL 60061 |
| Contact | Richard M Bilof |
| Correspondent | Richard M Bilof ARZCO MEDICAL ELECTRONICS, INC. 1029 BUTTERFIELD RD. (DUPLICATE/1927197) Vernon Hills, IL 60061 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-01 |
| Decision Date | 1991-04-26 |