The following data is part of a premarket notification filed by Dr. Mach Gmbh & Co. Kg with the FDA for Mach Led 2mc.
| Device ID | K140461 |
| 510k Number | K140461 |
| Device Name: | MACH LED 2MC |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | DR. MACH GMBH & CO. KG FEHMARNSTRASSE 31 Norderstedt, Schleswig-holstein, DE 22846 |
| Contact | Gudrun Busch, Ph.d. |
| Correspondent | Gudrun Busch, Ph.d. DR. MACH GMBH & CO. KG FEHMARNSTRASSE 31 Norderstedt, Schleswig-holstein, DE 22846 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-04-03 |
| Summary: | summary |