Medline's Examin, Operating Room/Surg Lights/Lamps
FDA 510(k) K931675 · Medline Industries, Inc.
510(k) numberK931675
Submission
- Device name
- Medline's Examin, Operating Room/Surg Lights/Lamps
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- April 6, 1993
- Decision date
- February 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTD – Lamp, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| K071180 | Scintillant Surgical Light, Model 2644-01-0001FTD · Traditional | Engineered Medical Solutions Co., LLC | 06/20/2007SE |
| K053364 | Halux Iris Examination and Surgical LampFTD · Traditional | Waldmann Lighting | 02/23/2006SE |
| K041681 | Atricure DissectorFTD · Traditional | AtriCure, Inc. | 07/01/2004SE |
| K013242 | Amsco Harmony Surgical Lighting and Media SystemFTD · Abbreviated | STERIS Corporation | 12/13/2001SE |
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Questions and answers
When was Medline's Examin, Operating Room/Surg Lights/Lamps cleared by the FDA?
Medline's Examin, Operating Room/Surg Lights/Lamps (K931675) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 322 days after the submission was received.
What is the product code of K931675?
The FDA product code is FTD – Lamp, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4580.