The following data is part of a premarket notification filed by Aristo Medical Products, Inc. with the FDA for Aristo Esophageal Stethoscope.
| Device ID | K961060 |
| 510k Number | K961060 |
| Device Name: | ARISTO ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | ARISTO MEDICAL PRODUCTS, INC. P.O. BOX 1637 Waukesha, WI 53187 -2345 |
| Contact | Stephen H Gorski |
| Correspondent | Stephen H Gorski ARISTO MEDICAL PRODUCTS, INC. P.O. BOX 1637 Waukesha, WI 53187 -2345 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-18 |
| Decision Date | 1996-06-19 |