The following data is part of a premarket notification filed by Sharn, Inc. with the FDA for Esophageal Stethoscope.
| Device ID | K860558 |
| 510k Number | K860558 |
| Device Name: | ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal |
| Applicant | SHARN, INC. 1300 NORTH WESTSHORE BLVD. Tampa, FL 33607 |
| Contact | Bruce A Tomlinson |
| Correspondent | Bruce A Tomlinson SHARN, INC. 1300 NORTH WESTSHORE BLVD. Tampa, FL 33607 |
| Product Code | BZW |
| CFR Regulation Number | 868.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-04-01 |