The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for T-scope, Telemetric Precordial Stethoscope.
| Device ID | K894757 |
| 510k Number | K894757 |
| Device Name: | T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | LOUISVILLE LABORATORIES, INC. 50 GOLDEN BALL RD. Weston, MA 02193 |
| Contact | David Phelps |
| Correspondent | David Phelps LOUISVILLE LABORATORIES, INC. 50 GOLDEN BALL RD. Weston, MA 02193 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-09-18 |