K900104 is an FDA 510(k) clearance for the TCPM II TOURNIQUET CUFF PRESSURE MONITOR. This device is classified as a Tourniquet, Pneumatic (Class I — General Controls, product code KCY).
Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on March 15, 1990, 65 days after receiving the submission on January 9, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K900104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1990 |
| Decision Date | March 15, 1990 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KCY — Tourniquet, Pneumatic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.5910 |