The following data is part of a premarket notification filed by Vsr Enterprises Corp. with the FDA for V*s*r(tm) Scope.
| Device ID | K895545 |
| 510k Number | K895545 |
| Device Name: | V*S*R(TM) SCOPE |
| Classification | Stethoscope, Manual |
| Applicant | VSR ENTERPRISES CORP. P.O. BOX 819 Walton Beach, FL 32549 |
| Contact | Eggers, Jr. |
| Correspondent | Eggers, Jr. VSR ENTERPRISES CORP. P.O. BOX 819 Walton Beach, FL 32549 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-13 |
| Decision Date | 1989-11-15 |