The following data is part of a premarket notification filed by Science Development Corp. with the FDA for Esophageal Stethoscope.
| Device ID | K830329 |
| 510k Number | K830329 |
| Device Name: | ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal |
| Applicant | SCIENCE DEVELOPMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZW |
| CFR Regulation Number | 868.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-01 |
| Decision Date | 1983-03-11 |