The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Tcpm Ii Tourniquet Cuff Pressure Monitor.
| Device ID | K900104 |
| 510k Number | K900104 |
| Device Name: | TCPM II TOURNIQUET CUFF PRESSURE MONITOR |
| Classification | Tourniquet, Pneumatic |
| Applicant | ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Contact | Harold W Bryan |
| Correspondent | Harold W Bryan ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-09 |
| Decision Date | 1990-03-15 |