The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Aim 200, Major Surgical Light.
| Device ID | K101537 |
| 510k Number | K101537 |
| Device Name: | AIM 200, MAJOR SURGICAL LIGHT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Contact | Scot Kinghorn |
| Correspondent | Scot Kinghorn BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2010-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858480006209 | K101537 | 000 |
| 00858480006100 | K101537 | 000 |
| 00858480006094 | K101537 | 000 |
| 00858480006087 | K101537 | 000 |
| 00858480006070 | K101537 | 000 |
| 00858480006063 | K101537 | 000 |