The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Supra Scope.
| Device ID | K801050 |
| 510k Number | K801050 |
| Device Name: | SUPRA SCOPE |
| Classification | Stethoscope Head |
| Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZS |
| CFR Regulation Number | 868.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-05 |
| Decision Date | 1980-05-14 |