The following data is part of a premarket notification filed by Biomedical Concepts, Inc. with the FDA for Lifesound(tm) Esophageal Stethoscope W/thermistor.
| Device ID | K864858 |
| 510k Number | K864858 |
| Device Name: | LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | BIOMEDICAL CONCEPTS, INC. 85 EXECUTIVE BLVD. Elmsford, NY 10523 |
| Contact | John R Graham |
| Correspondent | John R Graham BIOMEDICAL CONCEPTS, INC. 85 EXECUTIVE BLVD. Elmsford, NY 10523 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-03-10 |