The following data is part of a premarket notification filed by K & S Medicorp with the FDA for Saltzman Ear(tm) Endotracheal Ascultation Receptor.
| Device ID | K862131 |
| 510k Number | K862131 |
| Device Name: | SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | K & S MEDICORP 7860 S.W. 147 ST. Miami, FL 33158 |
| Contact | Robert E Saltzman |
| Correspondent | Robert E Saltzman K & S MEDICORP 7860 S.W. 147 ST. Miami, FL 33158 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-07-14 |