The following data is part of a premarket notification filed by Sharp Corporation with the FDA for Electronic Stethoscope.
| Device ID | K121144 |
| 510k Number | K121144 |
| Device Name: | ELECTRONIC STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | SHARP CORPORATION 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford SHARP CORPORATION 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-09-26 |
| Summary: | summary |