The following data is part of a premarket notification filed by Primrose Medical, Inc. with the FDA for Esophageal Stethoscopes.
| Device ID | K843070 |
| 510k Number | K843070 |
| Device Name: | ESOPHAGEAL STETHOSCOPES |
| Classification | Stethoscope, Esophageal |
| Applicant | PRIMROSE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZW |
| CFR Regulation Number | 868.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-06 |
| Decision Date | 1984-08-24 |