The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Cypress Medical Products Stethoscope.
| Device ID | K945082 |
| 510k Number | K945082 |
| Device Name: | CYPRESS MEDICAL PRODUCTS STETHOSCOPE |
| Classification | Stethoscope, Manual |
| Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Ken Rysso |
| Correspondent | Ken Rysso CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-17 |
| Decision Date | 1994-12-08 |