The following data is part of a premarket notification filed by Biomedical Concepts, Inc. with the FDA for Lifesound - Electronic Stethoscope.
| Device ID | K844804 |
| 510k Number | K844804 |
| Device Name: | LIFESOUND - ELECTRONIC STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | BIOMEDICAL CONCEPTS, INC. 14 LEE AVE. White Plans, NY 10606 |
| Contact | John R Graham |
| Correspondent | John R Graham BIOMEDICAL CONCEPTS, INC. 14 LEE AVE. White Plans, NY 10606 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-11 |
| Decision Date | 1985-02-13 |