The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Pressure Sentry Tourniquet.
| Device ID | K840206 |
| 510k Number | K840206 |
| Device Name: | PRESSURE SENTRY TOURNIQUET |
| Classification | Tourniquet, Pneumatic |
| Applicant | RICHARDS MEDICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-19 |
| Decision Date | 1984-04-25 |