K861289 is an FDA 510(k) clearance for the BASIC LIGHT. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).
Submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on April 18, 1986, 11 days after receiving the submission on April 7, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.
| 510(k) Number | K861289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1986 |
| Decision Date | April 18, 1986 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KZF — Device, Medical Examination, Ac Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6320 |