K101537 is an FDA 510(k) clearance for the AIM 200, MAJOR SURGICAL LIGHT. This device is classified as a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY).
Submitted by Burton Medical Products Corp. (Chatsworth, US). The FDA issued a Cleared decision on September 30, 2010, 119 days after receiving the submission on June 3, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K101537 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2010 |
| Decision Date | September 30, 2010 |
| Days to Decision | 119 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 |