The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Esophageal Stethoscope W/thermistor.
| Device ID | K873344 |
| 510k Number | K873344 |
| Device Name: | ESOPHAGEAL STETHOSCOPE W/THERMISTOR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Rachel D Richardson |
| Correspondent | Rachel D Richardson MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-19 |
| Decision Date | 1987-10-20 |