K922282 is an FDA 510(k) clearance for the ILLUMINATOR VIII ULTRA/SPOT. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).
Submitted by Medical Illumination, Inc. (Arleta, US). The FDA issued a Cleared decision on March 4, 1993, 293 days after receiving the submission on May 15, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.
| 510(k) Number | K922282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 1992 |
| Decision Date | March 04, 1993 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KZF — Device, Medical Examination, Ac Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6320 |