K893803 is an FDA 510(k) clearance for the FEVER LINE AND FEVER LINE PLUS. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).
Submitted by Liquid Crystal Sciences, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 21, 1989, 91 days after receiving the submission on May 22, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2200.
| 510(k) Number | K893803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1989 |
| Decision Date | August 21, 1989 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KPD — Strip, Temperature, Forehead, Liquid Crystal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2200 |