Mach LED 2MC
FDA 510(k) K140461 · Dr. Mach GmbH & Co. KG
510(k) numberK140461
Submission
- Device name
- Mach LED 2MC
- Applicant
- Dr. Mach GmbH & Co. KG
Norderstedt, Schleswig-Holstein, DE - Received
- February 24, 2014
- Decision date
- April 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FSY – Light, Surgical, Ceiling Mounted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K142984 | Leo MinorFSY · Traditional | Sunnex, Inc. | 10/29/2014SE |
| K142076 | Claveguard Freedom Surgical LightFSY · Traditional | Dickson & Dickson Healthcare (Us), Inc. | 09/30/2014SE |
| K140812 | MI-750 Procedural/Minor Surgical LightFSY · Traditional | Medical Illumination International, Inc. | 08/07/2014SE |
| K132551 | ZF 720FSY · Traditional | Umbel Corporation | 06/30/2014SE |
| K140930 | Vida LED Surgical Lighting System, V SeriesFSY · Traditional | Convida Healthcare & Systems Corporation | 06/09/2014SE |
| K140460 | Mach LED 2SCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K132747 | Visum Blade LED Surgical Lighting SystemFSY · Traditional | Stryker Communications | 12/30/2013SE |
| K132307 | Vida LED Surgical Lighting SystemFSY · Traditional | Convida Healthcare & Systems Corporation | 11/05/2013SE |
| K131893 | Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional | Ajw Technology Consultants, Inc. | 10/30/2013SE |
| K122875 | Oricare L2700FSY · Traditional | Oricare, Inc. | 12/18/2012SE |
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Questions and answers
When was Mach LED 2MC cleared by the FDA?
Mach LED 2MC (K140461) received a 510(k) decision of Substantially Equivalent on April 3, 2014, 38 days after the submission was received.
What is the product code of K140461?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.