Val Lux 600 Surgical Light (Plus and RS), Model ML600/S: Single Light Head, ML600/SS: Single Light Head, ML600/1D): Doub
FDA 510(k) K010716 · Valmed Corp.
510(k) numberK010716
Submission
- Device name
- Val Lux 600 Surgical Light (Plus and RS), Model ML600/S: Single Light Head, ML600/SS: Single Light Head, ML600/1D): Doub
- Applicant
- Valmed Corp.
Washington, DC, US - Received
- March 9, 2001
- Decision date
- May 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K132307 | Vida LED Surgical Lighting SystemFSY · Traditional | Convida Healthcare & Systems Corporation | 11/05/2013SE |
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Questions and answers
When was Val Lux 600 Surgical Light (Plus and RS), Model ML600/S: Single Light Head, ML600/SS: Single Light Head, ML600/1D): Doub cleared by the FDA?
Val Lux 600 Surgical Light (Plus and RS), Model ML600/S: Single Light Head, ML600/SS: Single Light Head, ML600/1D): Doub (K010716) received a 510(k) decision of Substantially Equivalent on May 30, 2001, 82 days after the submission was received.
What is the product code of K010716?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.