K981081 is an FDA 510(k) clearance for the BRIGHTSTAR. This device is classified as a Light, Surgical, Ceiling Mounted (Class II - Special Controls, product code FSY).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on April 29, 1998, 36 days after receiving the submission on March 24, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K981081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1998 |
| Decision Date | April 29, 1998 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSY — Light, Surgical, Ceiling Mounted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |