K934941 is an FDA 510(k) clearance for the E-Z TEMP II. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).
Submitted by Seven C'S, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 27, 1994, 282 days after receiving the submission on October 18, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2200.
| 510(k) Number | K934941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1993 |
| Decision Date | July 27, 1994 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KPD — Strip, Temperature, Forehead, Liquid Crystal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2200 |