The following data is part of a premarket notification filed by Transmedica, Inc. with the FDA for Transmedica Model 100 Digital Electronic Stethoscope.
| Device ID | K963418 |
| 510k Number | K963418 |
| Device Name: | TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | TRANSMEDICA, INC. 2112B GALLOWS RD. Vienna, VA 22182 |
| Contact | Sailor H Mohler |
| Correspondent | Sailor H Mohler TRANSMEDICA, INC. 2112B GALLOWS RD. Vienna, VA 22182 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1997-05-02 |
| Summary: | summary |